CONSIDERATION
99 We do not accept the thrust of AFT's submissions and we are not persuaded that the learned primary judge fell into error as alleged.
100 In 2017 AFT engaged in a comparative advertising campaign for Maxigesic in which it targeted other OTC paracetamol/ibuprofen combinations sold in Australia. The advertisements represented that when taken at their respective recommended maximum daily doses Maxigesic provides stronger and more effective relief from all pain than Nuromol and any other OTC paracetamol and ibuprofen combination analgesic. The representations were unqualified and they carried an unqualified representation that they were a statement of scientific fact and that there is an adequate scientific foundation for them.
101 AFT submits that the learned primary judge's 'critical error' was a failure, when evaluating the body of scientific evidence, to correctly apply the applicable legal test in relation to the adequacy of the scientific foundation for the representations and the onus, but it does not challenge any of the primary judge's findings about the scientific evidence.
102 There is no dispute between the parties as to the role of an appellate court in relation to findings of a trial judge which involved an evaluative assessment of the evidence, where the underlying facts are established by the findings and are no longer in dispute, and where no question as to the credibility of witnesses is involved. Both parties accept that the appropriate appellate approach was captured by Perram J in Aldi Foods Pty Ltd v Moroccanoil Israel Ltd [2018] FCAFC 93; (2018) 261 FCR 301 (Aldi) at [49]. As his Honour said, the Court's appellate jurisdiction is an appeal by way of rehearing, and involves the correction of error. In a case like the present, error is not demonstrated merely because the appellate court disagrees with the primary judge and to succeed in the appeal the appellant must establish error. Such error may be shown in a number of ways:
On the one hand, error may appear syllogistically where it is apparent that the conclusion which has been reached has involved some false step; for example, where some relevant matter has been overlooked or some extraneous consideration taken into account which ought not to have been. But error, on the other hand, may also appear without any such explicitly erroneous reasoning. The result may be such as simply to bespeak error. Allsop J said in such cases an error may be manifest where the appellate court has a sufficiently clear difference of opinion: Branir at 437-438 [29].
103 AFT adopts the approach in Aldi at [49] and urges us to review the primary judge's evaluation of the evidence and determine that there has been a false step, an overlooking of relevant matters or the taking into account of extraneous considerations. Alternatively, it submits that the result bespeaks error and that this Court should conclude that it has a clear difference of opinion to that the primary judge.
104 However, one real difficulty for AFT in establishing that the primary judge erred in evaluating the scientific evidence is that there was no scientific study before her Honour which directly related to the efficacy of Maxigesic or Nuromol at their respective recommended maximum daily doses. None of the scientific studies provided a direct, head-to-head comparison of the efficacy of analgesic products with the same levels of paracetamol/ibuprofen as Maxigesic and Nuromol at maximum daily doses. While there were scientific studies which compared the efficacy of 1000mg paracetamol/400mg ibuprofen with 500mg paracetamol/200mg ibuprofen, being the active pharmaceutical ingredients in single doses of Maxigesic and Nuromol, the representations concerned comparative efficacy at recommended maximum daily doses rather than single doses. Further, a single dose of Maxigesic contains 1000mg paracetamol/300mg ibuprofen whereas the comparative studies in relation to paracetamol/ibuprofen combinations considered the comparative efficacy of 1000mg paracetamol/400mg ibuprofen, being 100mg more ibuprofen than Maxigesic.
105 The parties sought to extrapolate from the studies to advance their respective contentions. The primary judge was therefore required to consider the scientific studies, some of which favoured Reckitt's contentions and some which favoured AFT's contentions, and the parties' submissions as to what could be extrapolated from the studies in order to decide whether Reckitt established that there is no adequate scientific foundation for the representations.
106 The primary judge carefully considered and weighed the evidence in relation to the scientific studies. It is worth noting that her Honour's consideration of the studies and the relevant scientific issues ran from [115]-[201]. Amongst other things, her Honour found that:
(a) the Mehlisch No. 2 study did not find a statistically significant difference in efficacy between 1000mg paracetamol/400mg ibuprofen and 500mg paracetamol/200mg ibuprofen (at [138]);
(b) the Mehlisch No. 2 study is scientific evidence that a combination of 1000mg paracetamol/400mg ibuprofen is not a more effective dose than 500mg paracetamol/200mg ibuprofen, and scientific evidence of a ceiling in the effectiveness of paracetamol and ibuprofen at the dosage of Nuromol (at [141];
(c) the more comprehensive Mehlisch No. 2 study cast doubt on the results reported in the earlier Daniels study and the Mehlisch No. 1 study (at [196]);
(d) while the Doherty study found a difference in efficacy between 1000mg paracetamol/400mg ibuprofen and 500mg paracetamol/200mg ibuprofen, it was not of statistical significance and it did not involve a direct comparison with a single dose of Maxigesic which contains 1000mg paracetamol/300mg ibuprofen (at [127]);
(e) the Moore review was inconclusive as to whether 1000mg paracetamol/400mg ibuprofen is more efficacious than 500mg paracetamol/200mg ibuprofen (at [157]);
(f) the Derry review was inconclusive as to whether 400mg ibuprofen provides more effective pain relief than 200mg ibuprofen (at [166]); and
(g) the Toms review did not find a significant difference in the NNT for 500mg paracetamol compared to 1000mg paracetamol (at [169]).
In light of these unchallenged findings it is difficult to see merit in AFT's contention that her Honour erred in evaluating the evidence and concluding that there is no adequate foundation in science for its unqualified claims of Maxigesic's superiority.
107 Of course, some of the scientific studies provide some support for AFT's position. We do not mean this pejoratively, but AFT's submissions 'cherry picked' the evidence in that regard. The existence of some favourable studies is, however, insufficient to show that the primary judge erred in assessing the evidence and reaching the conclusion that she did.
108 Her Honour enumerated seven matters to support the conclusion that there is not an adequate scientific foundation for the impugned representations (at [203]), which matters must be considered collectively and cumulatively. Overall we respectfully consider they provide a cogent basis for the learned primary judge's conclusion that there is no adequate scientific foundation for the representations.
109 First, at [203(1)], her Honour noted that there was no clinical study or meta-analysis before the Court which supports AFT's representations by a trial of the comparative pain relief provided by Maxigesic and Nuromol or comparable doses of paracetamol/ibuprofen combinations.
110 AFT accepts that there is no such clinical study or meta-analysis but submits that the primary judge should have given no weight to the absence of a head to head comparison of the efficacy of Maxigesic and Nuromol. We disagree. In our view it was relevant for her Honour to note that no clinical study or meta-analysis directly compared the two products at their recommended maximum daily doses. The consequence of the absence of a direct head-to-head comparison was that the question of the adequacy of the scientific foundation had to be considered by extrapolation, a factor that could confound the clarity of the expression of scientific views.
111 AFT contends that the absence of a head-to-head comparison cannot be said to establish that there is no adequate scientific foundation for its representations of superiority when, on its argument, there was a substantial body of scientific evidence before the Court relating to the efficacy of different doses of paracetamol/ibuprofen combinations and to those analgesics as monotherapies. That contention however begs the question as to the substantiality of the scientific evidence which supports AFT's position. Her Honour made unchallenged findings about the scientific evidence and did not accept AFT's contentions about that evidence. In our respectful view and having regard to the totality of the scientific evidence before the Court, her Honour's assessment of the appropriate balance of the evidence was plainly open.
112 Similarly, there is little force in AFT's contention that a head-to-head comparison would involve an expensive human clinical trial and there was already a large body of supportive medical evidence, such that there was no warrant for requiring it to adduce a head-to-head comparison. As we have said, the primary judge took a different view as to the substantiality of the scientific evidence which supports AFT's position, which view we respectfully consider was open on the evidence.
113 AFT further submits that, the primary judge having found that Reckitt had not established a ceiling in the effective dose for paracetamol/ibuprofen combinations at 500mg paracetamol/200mg ibuprofen, the evidence of both Professors Christie and Rolan supported the conclusion that a head-to-head comparison was not required to support the representations. That submission overstates the position. Her Honour concluded that there is an unresolved question in the science as to the existence or otherwise of a relevant analgesic ceiling (at [192]). The primary judge did not find that a head-to-head comparison was required in every case to justify claims of the kind made by AFT. Rather, her Honour noted the absence of such a comparison and took it into account as one relevant factor in her assessment of the totality of the scientific evidence before the Court. Her Honour did not treat the absence of a head-to-head study as sufficient on its own to demonstrate the lack of an adequate scientific foundation.
114 Second, at [203(2)], the primary judge noted that Professors Rolan and Christie agreed that "there are insufficient data to determine whether Nuromol and Maxigesic have different maximal effect after [a] single dose".
115 AFT accepts that such data was insufficient, but contends that the primary judge should not have put any weight upon this because its representations as to Maxigesic's superior pain relief concerned the pain relief provided when the competing paracetamol/ibuprofen combinations were taken at their respective recommended maximum daily doses.
116 In our view the primary judge's uncontentious observation was apposite, and a matter upon which it was appropriate for her Honour to rely, because:
(a) in relation to the adequacy of a scientific foundation for the representations, both parties sought to extrapolate the results from single doses to the recommended maximum daily doses. The insufficiency of the data at the level of single doses was relevant;
(b) the expert witnesses' agreement as to the insufficiency of the data in relation to comparative pain relief after a single dose tends to indicate that data is also required to show the comparative efficacy of Maxigesic and Nuromol at their respective recommended maximum daily doses; and
(c) the only two clinical studies to assess multiple doses of paracetamol/ibuprofen combinations were the Mehlisch No. 2 study and the Doherty study. Both of those studies found there was no significant difference in efficacy between 1000mg paracetamol/400mg ibuprofen and 500mg paracetamol/200mg ibuprofen over multiple doses.
In any event the primary judge did not treat the insufficiency of the data regarding single doses as sufficient of itself to show the absence of an adequate scientific foundation. It was only one consideration upon which her Honour drew regarding the adequacy of the scientific foundation for the representations.
117 Third, at [203(3)] the primary judge found (emphasis added):
Although there is evidence that 400mg ibuprofen is more effective than 200mg ibuprofen (Mehlisch No. 1 study, Moore review and Rabbie review), the totality of the scientific evidence concerning the absence of a relevant analgesic ceiling is not so conclusive that the relevant body of scientific knowledge can be taken to include the absence of such a ceiling. Accordingly, I am not persuaded that there is an adequate scientific foundation for the representations based on extrapolation from the studies relied upon by AFT.
118 This finding reflects her Honour's anterior findings at [192] that there is an unresolved question in the science as to the existence or otherwise of a relevant analgesic ceiling, that Reckitt had not established a ceiling at the level of a single dose of Nuromol, and that on the other hand AFT had not established there is no relevant ceiling.
119 AFT argues that the primary judge set the bar too high by stating that the evidence concerning the absence of a relevant analgesic ceiling is "not so conclusive" that the relevant body of scientific knowledge can be taken to include the absence of such a ceiling. AFT accepts though that the primary judge correctly identified the applicable test, and it alleges only that the primary judge misapplied it. In our view in using the expression "not so conclusive" the primary judge was merely reiterating the view she expressed at [192], that there is an unresolved question in the science as to the existence or otherwise of a relevant analgesic ceiling.
120 AFT submits that the finding at [203(3)], and the anterior findings at [192], reflect an additional error, because her Honour incorrectly reversed the onus. In essence AFT argues that it did not have the onus to establish anything. It contends that Reckitt failed to discharge its onus because the scientific evidence upon which it relied merely raised the possibility, without establishing, that the representations lacked an adequate scientific foundation. It also contends that that the onus could not be discharged on the basis of the primary judge's finding that there is an unresolved question in the science as to the existence or otherwise of a relevant analgesic ceiling. It says Reckitt had the onus to establish the existence of such a ceiling and it failed to do so.
121 In our view these contentions do not adequately address the learned primary judge's reasoning. As the primary judge noted at [184], Reckitt did not contend that it was necessary to establish such a ceiling in order to discharge its onus. It argued, and the primary judge implicitly accepted, that it was sufficient for Reckitt to establish its case if it satisfied her Honour that the scientific evidence was inconclusive, such that there was no adequate scientific foundation for the representations. As the primary judge correctly said at [202]:
...the issue for determination is whether there is an adequate scientific foundation for the relevant representations of fact.
122 AFT is correct in contending that before the primary judge Reckitt argued that the scientific evidence supported the existence of a relevant analgesic ceiling and it failed to prove that. But it is also the case that AFT challenged that proposition and advanced an affirmative argument to the effect that the evidence demonstrated that there is in fact no ceiling. The primary judge considered the evidentiary matters upon which the parties had relied in relation to the question of the analgesic ceiling and concluded (at [192]) that Reckitt had not discharged its evidentiary onus of establishing that there is a relevant analgesic ceiling. Her Honour also found that AFT, which had set out to establish that there is no such ceiling, had failed to discharge the evidentiary burden that it had adopted. The result of those dual failures was that the evidence revealed an unresolved question in the science as to existence of such a ceiling.
123 In many cases which concern alleged misrepresentations, such evidentiary findings would be insufficient to found a conclusion that a representation of fact was misleading or deceptive. But in the present case, AFT represented that there is an adequate foundation in scientific knowledge for the unequivocal claim that at their respective recommended maximum daily doses, Maxigesic provides stronger and more effective pain relief than Nuromol and other OTC paracetamol/ibuprofen combinations. If the primary judge found that Reckitt established that there is no adequate scientific foundation for that representation, either because the science conclusively disproved the claim or because the science was inconclusive such that it did not provide an adequate foundation, then Reckitt would succeed in the case.
124 This can be seen in the observation of Burchett J in Janssen at 234 where his Honour said "[o]f course it is correct that the onus is on the applicant, but it seems to me that proof that there is no scientific foundation for a statement in the realm of a science may be sufficient proof that the statement is misleading." The learned primary judge did not err by taking into account the totality of the scientific evidence and concluding on the balance of the evidence: (a) at [192], that there is an unresolved question in the science as to the existence or otherwise of a relevant analgesic ceiling; or (b) at [203(3)], that the evidence concerning the absence of a relevant analgesic ceiling was "not so conclusive" that the relevant body of scientific knowledge could be taken to include the absence of such a ceiling.
125 Amongst other things, her Honour's conclusion is supported by findings at [141], unchallenged in the appeal, that the Mehlisch No. 2 study is scientific evidence that a combination of 1000mg paracetamol/400mg ibuprofen is not a more effective dose than 500mg paracetamol/200mg ibuprofen and scientific evidence of a ceiling in the effectiveness of paracetamol and ibuprofen at the level of a single dose of Nuromol. Nor did her Honour err by taking that into account as one of the matters supporting the conclusion that there is no adequate scientific foundation for AFT's representations of superiority: see RB v GSK at [41]. We do not consider that the learned primary judge incorrectly reversed the onus of proof.
126 Fourth, at [203(4)] the primary judge found that the Mehlisch No. 2 study is a "significant part of the body of scientific knowledge concerning the truth or otherwise of the representations" and that it "tends to suggest that the representations may be false".
127 AFT does not challenge this finding but argues that it is insufficient to support a conclusion that there is no adequate scientific foundation for the representations. However, the primary judge did not treat this finding as sufficient of itself to show the absence of an adequate scientific foundation for the representations. Her Honour merely stated it as one of the matters which cumulatively and collectively supported her conclusion. In any event, in our respectful view, her Honour's finding that the Mehlisch No. 2 study is a significant part of the body of scientific knowledge is plainly correct. Her Honour's finding that it tends to suggest that there is no adequate scientific foundation for the representations is, with respect cogent. Taken overall, as a summary of the evidence considered and a conclusion based on it, we consider her Honour's statement to be unexceptionable.
128 Fifth, the same is true of the finding at [203(5)] where the primary judge said that the Moore and Derry reviews "cast doubt on the truthfulness of the representations" because they indicate that the science is inconclusive as to whether 1000mg paracetamol/400mg ibuprofen is more efficacious than 500mg paracetamol/200mg ibuprofen, and as to whether 400mg ibuprofen is more efficacious than 200mg ibuprofen.
129 AFT argues that the primary judge's reasoning demonstrates a misapplication of the accepted test for adequacy of scientific foundation. We disagree. In our view, the statement is based in her Honour's anterior findings that:
(a) the Moore review is inconclusive as to whether 1000mg paracetamol/400mg ibuprofen is more efficacious than 500mg paracetamol/200mg ibuprofen (at [157]); and
(b) the Derry review is inconclusive as to whether 400mg ibuprofen is more effective than 200mg ibuprofen (at [166]).
130 Having regard to those unchallenged findings, and also in light of the primary judge's findings in relation to Mehlisch No. 2 study, we consider her Honour's conclusion that they cast doubt on the truthfulness of the representations is unexceptionable. The fact that these reviews provided inconclusive results, when they each provided data relevant to whether relevant doses of analgesics provided different efficacy, was a material factor that was appropriate for her Honour to weigh in the mix of factors that underpinned the conclusion that there was not an adequate scientific foundation for the representations. The primary judge did not treat this finding as sufficient of itself to show the absence of an adequate scientific foundation for the representations, and her Honour's observation that the Moore and Derry reviews cast doubt on the truthfulness of the representations is, with respect, persuasive.
131 Sixth, at [203(6)] the primary judge found that, in light of the Mehlisch No. 2 study and the Moore and Derry reviews, the Mehlisch No. 1 study did not provide an adequate scientific foundation for the representations.
132 In relation to the primary judge's reliance on the Moore review and the Derry review, AFT again contends that the NNT metric has significant limitations in measuring comparative pain relief. It argues that this was demonstrated by Professor Rolan's evidence, which also showed that such reviews produced limited findings and often lacked clinically important information. Even if accepted, that does not show the primary judge erred as alleged. Her Honour did not miss or mistake Professor Rolan's evidence as to limitations to be borne in mind when considering comparative NNTs across meta-analyses. Her Honour expressly took that evidence into account (at [157], [163] and [166]). Having done so, and in light of her earlier finding that Cochrane reviews are one of the "gold standards" used for the translation of clinical practice in trials, her Honour concluded that these reviews, together with the Mehlisch No. 2 study, meant that the Mehlisch No. 1 study does not provide an adequate scientific foundation for the representations. We respectfully agree.
133 AFT also submits that the Moore review and the Derry review 2 support the impugned representations, but that the primary judge found that they were inconclusive as they did not include a statistical analysis. It argues that an absence of a statistical analysis does not mean there was no adequate scientific foundation for the representations. In our view this submission has little force.
134 First, in considering the Moore review (at [152]-[157]) the primary judge did not state that the basis of her finding that the review was inconclusive was an absence of statistical analysis. AFT did not provide a reference to show that the finding was so based.
135 Second, AFT makes no challenge to the primary judge's finding that the Moore review was inconclusive as to whether 1000mg paracetamol/400mg ibuprofen is more efficacious than 500mg paracetamol/200mg.
136 Third, AFT's attempt to rely on the Derry review 2 is misplaced. AFT submits that it demonstrates that 1000mg paracetamol/400mg ibuprofen provides superior pain relief than 500mg paracetamol/200mg ibuprofen. However, for reasons which are not apparent to us, and about which the parties made no submissions, the primary judge made no findings about the Derry review 2 and AFT does not contend that Her Honour should have done so.
137 AFT argues that the primary judge was referring to both the Derry review and the Derry review 2 when her Honour said (at [203(5)]) that "[t]he Moore and Derry reviews also cast doubt on the truthfulness of the representations". We do not accept that. The Derry review considered the comparative efficacy of 400mg ibuprofen and 200mg ibuprofen as a monotherapy, and the primary judge referred to that review at [161]-[162] and made findings in relation to it. The Derry review 2 considered the comparative efficacy of 1000mg paracetamol/400mg ibuprofen and 500mg paracetamol/200mg ibuprofen. The primary judge did not refer to the latter study (except perhaps at [112(6)] when setting out the matters upon which Reckitt relied to prove the absence of an adequate scientific foundation) and her Honour made no findings about its results.
138 Finally, we have considered the Derry review 2 and we do not consider it shows that the primary judge erred in evaluating the evidence overall. It found that the proportion of participants achieving at least 50% maximum pain relief over six hours was 69% with 500mg paracetamol/200mg ibuprofen and 73% with 1000mg paracetamol/400mg ibuprofen, compared to 7% with placebo. The test concerned single doses, and the different paracetamol/ibuprofen combinations had almost the same NNTs being 1.6 (1.5 to 1.8) for the 500/200 dose and 1.5 (1.4 to 1.7) for the 1000/400 dose. The review provides little scientific support for the claim that, at their respective recommended maximum daily doses, Maxigesic provides stronger and more effective pain relief than Nuromol and other paracetamol/ibuprofen combinations. It does not alter the balance of the evidence.
139 In relation to the Mehlisch No. 2 study, AFT accepts that the study did not find a statistically significant difference between 1000mg paracetamol/400mg ibuprofen and 500mg paracetamol/200mg ibuprofen. It argues however that by finding that 1000mg paracetamol/400mg ibuprofen was more effective than 400mg of ibuprofen whereas 500mg paracetamol/200mg ibuprofen was not, the study nevertheless provides evidence of a dose response above a single dose of Nuromol. The primary judge however found (at [196]) that, the Mehlisch No. 2 study casts doubt on the existence of an adequate scientific foundation for the representations, which finding is unchallenged.
140 There is little force in AFT's submissions in relation to the primary judge's finding at [203(6)] when her Honour's findings about the Mehlisch No. 2 study and the Moore and Derry reviews are not challenged in the appeal. Given the learned primary judge's unchallenged findings that:
(a) the Mehlisch No. 2 study:
(i) did not find a statistically significant difference in efficacy between 1000mg paracetamol/400mg ibuprofen and 500mg paracetamol/200mg ibuprofen (at [138]);
(ii) is scientific evidence of a ceiling in the effectiveness of paracetamol and ibuprofen at the level of a single dose of Nuromol (at [141]); and
(iii) casts doubt on whether the Mehlisch No. 1 study (and the Daniels study) provide an adequate scientific foundation for the representations (at [196])
(b) the Moore review is inconclusive as to whether 1000mg paracetamol/400mg ibuprofen is more efficacious than 500mg paracetamol/200mg ibuprofen (at [157]); and
(c) the Derry review is inconclusive as to whether 400mg ibuprofen is more effective than 200mg ibuprofen (at [166]);
her Honour's conclusion that the Mehlisch No. 1 study does not provide an adequate scientific foundation for the representations is, with respect, cogent. Those studies were material matters that it was appropriate for the primary judge to weigh in the mix of matters relevant to whether there is an adequate scientific foundation for the representations. It is relevant too that the Mehlisch No. 1 study was only a pilot or "proof of concept" study with a much smaller cohort of patients, and the Mehlisch No. 2 study was designed to confirm and extend the findings of the Mehlisch No.1 study but failed to do so. We are not persuaded that the primary judge placed undue reliance on those studies and can see no error in her Honour's assessment of the evidence in that regard.
141 Seventh, at [203(7)], the primary judge declined to give significant weight to overseas regulatory approvals of a different dosing regimen for Nuromol, in the absence of evidence of the scientific foundation for that dosing regimen which was accepted by overseas regulatory authorities.
142 It was not in dispute before the primary judge that:
(a) in other countries Reckitt has obtained regulatory approval for a single dose Nuromol comprising 1000mg paracetamol/400mg ibuprofen, that is, twice the Australian approved dose; and
(b) the approved single dose in Australia for Reckitt's ibuprofen monotherapy, Nurofen, was 400mg which is twice the amount of ibuprofen available in a single dose of Nuromol.
143 AFT submits that the primary judge erred by failing to find that Reckitt's approach to: (a) the dosing of Nuromol overseas was consistent with a single dose of 1000mg paracetamol/400mg ibuprofen having greater effect than a single dose of 500mg paracetamol/200mg ibuprofen; and (b) the dosing of Nurofen in Australia was consistent with a single dose of ibuprofen 400mg having greater effect than a single dose of 200mg. It argues that such findings would have provided further support for there being an adequate scientific foundation for the impugned representations.
144 Reckitt contended below that Maxigesic delivered no greater pain relief than Nuromol despite it containing higher quantities of paracetamol and ibuprofen, both in single and maximum daily doses. AFT submits that if that contention were accepted it would mean that the dosing regimens Reckitt proposed for Nuromol overseas and Nurofen in Australia involved consumers taking two capsules in a single dose when a second capsule was ineffective (but increased the side effects profile). It contends that it shows that Reckitt and its related businesses, which have specialist scientific expertise in the area, considered that these dosing regimens were appropriate. It argues that the primary judge's refusal to give weight to this matter failed to recognise that Reckitt is a sophisticated multinational group of pharmaceutical companies, and that it could not credibly be suggested that Reckitt sought and obtained regulatory approval for and marketed medicines with dosing regimens which involved large quantities of inefficacious active ingredients. It also pointed to the fact that those dosing regimens have been approved by pharmaceutical regulators overseas and the TGA in Australia. AFT contends that the fact of the regulatory approval is relevant and probative and that such dosing regimens were inconsistent with Reckitt's contentions in relation to the efficacy of the higher quantities of paracetamol and ibuprofen in Maxigesic. Having regard to Reckitt's onus to establish its case, AFT argues it was significant that Reckitt failed to explain the inconsistency.
145 In our respectful view the primary judge was entitled to reject AFT's argument based on the dosing regimens for Nuromol overseas and Nurofen in Australia in the absence of evidence that the relative benefits of the different doses were the subject of scientific evidence that was accepted by the relevant regulatory authorities. There may, for instance, have been commercial reasons unrelated to comparative efficacy for Reckitt to propose different dosing regimens, and there may have been other reasons why overseas regulatory authorities approved a higher level of paracetamol/ibuprofen, for instance, because there were already equivalent paracetamol/ibuprofen combinations available in that country. We do not however speculate about that and it suffices to observe that in the absence of specific evidence as to the scientific basis for the regulatory approvals, the existence of the other dosing regimens and the fact of the approvals, we do not consider that her Honour erred in declining to give such evidence any significant weight.
146 In circumstances where AFT published representations in 2017 to the unequivocal effect that there is a current adequate foundation in scientific knowledge that Maxigesic provides stronger and more effective relief from all pain than Nuromol and other OTC paracetamol/ibuprofen combinations at their respective recommended maximum daily doses, the primary judge did not err by taking into account the totality of the evidence at the time. That body of evidence included some scientific findings that supported the representations, but also cogent findings that did not support them. The result was that the simplistic statement as to comparative efficacy, which carried with it an unqualified and definitive statement of scientific fact, did not have an adequate scientific foundation.
147 The appeal must be dismissed with costs.
I certify that the preceding one hundred and forty-seven (147) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justices Murphy, Wigney and Burley.