FEDERAL COURT OF AUSTRALIA

AFT Pharmaceuticals (AU) Pty Limited v Reckitt Benckiser (Australia) Pty Limited [2020] FCAFC 45

ORDERS

THE COURT ORDERS THAT:

1.    The appeal be dismissed.

2.    The Appellant pay the Respondent’s costs of the appeal.

Note:    Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

REASONS FOR JUDGMENT

THE COURT:

INTRODUCTION

1    In this appeal the appellant AFT Pharmaceuticals (AU) Pty Ltd (AFT) and the respondent Reckitt Benckiser (Australia) Pty Ltd (Reckitt) are competitors in the sale of over-the-counter (OTC) analgesics in Australia. AFT markets and sells “Maxigesic” which is a combination of paracetamol and ibuprofen in tablet form and Reckitt markets and sells “Nuromol” which is a combination of paracetamol and ibuprofen in capsule form. Paracetamol and ibuprofen are the only active pharmaceutical ingredients in each of the competing products.

2    Maxigesic and Nuromol provide different doses of paracetamol/ibuprofen both at the level of a single dose and when taken at their respective recommended maximum daily doses:

(a)    A single dose of Nuromol is one capsule, which contains 500mg of paracetamol and 200mg of ibuprofen. The maximum recommended daily dose is three capsules which provides a total dose of 1500mg paracetamol/600mg ibuprofen.

(b)    A single dose of Maxigesic is two tablets, which taken together contain 1000mg of paracetamol and 300mg of ibuprofen. The maximum recommended daily dose is eight tablets which provides a total dose of 4000mg paracetamol/1200mg ibuprofen.

Thus, when taken at their maximum recommended daily doses Maxigesic provides 2500mg more paracetamol and 600mg more ibuprofen than Nuromol.

3    In 2017 AFT caused advertisements to be published in the trade publications Australian Journal of Pharmacy, Australian Family Physician and Bite, in a card distributed to pharmacies, and in a pamphlet distributed to pharmacists (the Maxigesic advertisements). The advertisements were directed to a target audience of health professionals, being pharmacists and support staff who advise consumers about OTC analgesics.

4    The primary judge found at [12] that the Maxigesic advertisements conveyed the following two representations:

(1)    Maxigesic provides stronger and more effective relief from all pain than Nuromol when taken at their respective maximum recommended daily doses (the First Representation).

(2)    When taken at their respective maximum recommended daily doses, Maxigesic provides stronger and more effective relief from pain than any other paracetamol/ibuprofen combination (the Second Representation).

The two representations are to the same effect because the evidence shows that while the recommended maximum daily dose for Maxigesic is unique, the other available OTC paracetamol/ibuprofen combinations in Australia all have the same dosing regimen as Nuromol. Her Honour further found that the Maxigesic advertisements also conveyed that those representations were grounded in scientific fact, and that the advertisements therefore conveyed a further representation that there is a current adequate foundation in scientific knowledge for each representation.

5    The appeal does not challenge the primary judge’s findings that the Maxigesic advertisements conveyed: (a) the First and Second Representations; (b) that those representations were grounded in scientific fact and (c) that there is an adequate scientific foundation for those representations.

6    The primary judge ultimately concluded that there was no adequate scientific foundation for the impugned representations. As a result her Honour found the representations misleading or deceptive or likely to mislead or deceive in contravention of s 18 of the Australian Consumer Law in Schedule 2 of the Competition and Consumer Act 2010 (Cth) (ACL), false or misleading in contravention of ss 29(1)(a) and 29(1)(g) of the ACL, and liable to mislead in contravention of s 33 of the ACL. The appeal challenges these findings.

7    AFT accepts that her Honour correctly identified the applicable legal principles in relation to whether Reckitt established that there is no current adequate scientific foundation for the representations, and that Reckitt bore the onus of establishing their falsity. AFT does not though challenge the numerous findings the primary judge made about the scientific evidence. Rather, it argues that in evaluating the evidence the primary judge failed to correctly apply the legal test and the onus.

8    For the reasons we explain the appeal must be dismissed with costs. Reckitt bore the onus of establishing that there was no adequate scientific foundation for the impugned representations and thus that they were misleading or likely to mislead. That did not require Reckitt to positively establish that, at their respective recommended daily doses, Maxigesic does not provide stronger and more effective relief from all pain than Nuromol and other OTC paracetamol/ibuprofen combinations. It was enough for Reckitt to establish that, taking into account the totality of the scientific evidence available at the relevant time, which included evidence going both ways, the balance of the scientific evidence did not provide an adequate scientific foundation for AFT’s simplistic representation that Maxigesic provides stronger and more effective relief from all pain than Nuromol and other OTC paracetamol/ibuprofen combinations, carrying as it did a representation that was an unqualified statement of scientific fact. We can see no error in the primary judge’s finding that there was no adequate scientific foundation for the impugned representations.

THE PRIMARY JUDGMENT

Adequate foundation in science for representations

9    The primary judge set out the applicable legal principles in relation to whether an adequate scientific foundation existed for the representations (at [29]-[41]).

10    AFT accepts that the primary judge correctly stated the principles but, because it contends that her Honour misapplied them, it is appropriate to set out the authorities upon which the primary judge relied.

11    Her Honour said that where claims are made of a scientific nature, proof that there is no adequate scientific foundation for those claims may be sufficient to establish that the claims are misleading, citing the decision in GlaxoSmithKline Australia Pty Ltd v Reckitt Benckiser (Australia) Pty Limited (No 2) [2018] FCA 1; (2018) 133 IPR 190 at [49] (Foster J), which was upheld on appeal in Reckitt Benckiser (Australia) Pty Limited v GlaxoSmithKline Australia Pty Ltd [2018] FCAFC 138 (RB v GSK) at [41] (McKerracher, Yates and Gleeson JJ).

12    Her Honour cited with approval the following decisions:

(a)    Janssen Pharmaceutical Pty Limited v Pfizer Pty Ltd [1985] FCA 574; (1985) 6 IPR 227 (Janssen) at 234 where Burchett J said (emphasis added):

Of 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.

This will be so where in its context the statement must be, or is likely to be, taken as implying that there is an adequate foundation in scientific knowledge to enable it to be made; cf Colgate Palmolive Pty Ltd v Rexona Pty Ltd (1981) 37 ALR 391.

(b)    Sterling Winthrop Pty Ltd v Boots Co (Australia) Pty Ltd [1995] FCA 664; (1995) 32 IPR 361 at 365, where in the context of an application for an interlocutory injunction, Tamberlin J stated:

It can also, in my view, be misleading to make a statement which implies that there is an adequate foundation in scientific knowledge to justify it when taken in its context the scientific statement quoted does not provide a proper foundation; cf Colgate-Palmolive Pty Ltd v Rexona Pty Ltd [1981] FCA 146; (1981) 37 ALR 391; ATPR 40-242; [1981] FCA 146; 58 FLR 391; Duracell Australia Pty Ltd v Union CaReckittide Australia Ltd (1988) 14 ALR 293; ATPR 40-918; Janssen Pharmaceutical Pty Ltd v Pfizer Pty Ltd (1986) ATPR 40-654.

(c)    Johnson & Johnson Pacific Pty Ltd v Unilever Australia Ltd (No 2) [2006] FCA 1646; (2006) 70 IPR 574 at [105], where Bennett J said (emphasis added):

The onus is on Johnson to establish that the representation was misleading and deceptive but, following Burchett J’s observations in Janssen Pharmaceutical Pty Ltd v Pfizer Pty Ltd (1986) 6 IPR 227 at 234, if Johnson establishes that there is no foundation in the study for a statement in the advertisements, that may be sufficient proof that the statement is misleading. As his Honour recognised, the question is whether the context in which the representation is made implies that adequate foundation exists for making it.

(d)    RB v GSK at [41] where the Full Court said (emphasis added):

When evaluating whether there was an adequate foundation in the body of scientific knowledge to support the representations that were made, the primary judge did not err by taking into account the totality of the scientific evidence available at the relevant time. Further, the primary judge did not err by concluding that it would be misleading or deceptive, or likely to mislead or deceive, to make the impugned representations on the basis of the Schachtel Study alone, when the balance of the scientific evidence demonstrated no clear-cut superiority of ibuprofen over paracetamol in terms of faster and more effective relief from pain caused by common headaches including TTH. The body of scientific evidence, which took into account the findings of the Schachtel Study, but balanced them against the findings of other studies, did not support the making of simplistic comparisons of the kind found in Reckitt’s comparative advertising material. It was misleading for Reckitt to make the representations it did—which carried with them an unqualified and definitive statement of scientific fact—when the overall conclusion to be drawn from the scientific evidence was that no authoritative comparisons between active treatments were possible in the then state of scientific knowledge.

(e)    Tobacco Institute of Australia Ltd v Australian Federation of Consumer Organisations Inc [1992] FCA 962; (1992) 38 FCR 1 (Sheppard, Foster & Hill JJ) in which the Full Court considered a representation that “there is little evidence and nothing which proves scientifically that cigarette smoke causes disease in non-smokers”. At 56, Hill J stated:

For the purposes of determining the falsity of the first part of the statement, it is unnecessary to embark upon a detailed study of the evidence criticising the studies which form the basis of the primary articles. I am, for the purposes of this part of the case, prepared to accept that many of the underlying studies suffer from defects, produce results which are not statistically significant and would not be accepted by all, or perhaps by even a majority of scientists, as rigorous proof in accordance with scientific method. But that does not mean that, looked at as a body of “evidence”, there is such a paucity that it could be dismissed as insignificant. A number of the studies show trends which, even if not statistically significant, point to an association and thus the possibility of a causal relationship between exposure to environmental tobacco smoke and cancer. A number of the Reviews accept these conclusions. That such an apparently authoritative body as the Surgeon General should, in its 1986 report, (albeit published after the date of the advertisement but based on studies available at that time) conclude the existence of causality is, even on its own, evidence of causality which is more than insignificant. Its existence, as even the existence of flawed (although not discredited in the major reviews) studies, makes the statement that there is little evidence that passive smoking causes disease in non-smokers misleading, or renders it likely to mislead.

13    In the appeal AFT did not suggest that her Honour erred in relying upon these authorities.

14    Before the primary judge AFT contended that a mere conflict in scientific views and/or the existence of conflicting scientific studies is insufficient to show that there is no adequate scientific foundation for a representation, as noted at [38]. It submitted that it is unsurprising that scientists might hold different views on an issue, and contended that the very fact that two eminently qualified scientists held different views on issues such as those in the present case strongly suggested that there is an adequate scientific foundation for both views. Similarly, AFT contended that the existence of conflicting clinical studies did not demonstrate that there is no scientific foundation for the conclusions reached in the conflicting studies, and it merely illustrates that even where the studies are conducted with rigour there may be variability in the outcomes. It submitted that the Court should only find that representations like those in the present case are misleading or likely to mislead where the scientific evidence is such that the impugned position cannot legitimately be maintained. Although it is not the primary thrust of AFT’s case in the appeal, its submissions in part echo this argument.

15    The primary judge did not accept this submission. Her Honour said (at [39]):

Of course, two eminently qualified scientists may reasonably hold contrary opinions about a matter of fact. However, where that is the case their disagreement necessarily casts doubt on whether the fact is true or false.

16    There were no direct head-to-head clinical studies which considered the comparative efficacy of Maxigesic and Nuromol before the primary judge. Her Honour found however that it may be possible to extrapolate from the results of one or more clinical studies to reach a conclusion or conclusions that, in turn, may form an adequate foundation in science for a representation that had been made (at [40]). Her Honour accepted the evidence of Professor Christie, a professor of pharmacology who gave evidence for Reckitt, who said (emphasis added):

The results from a single clinical trial can be tentatively extrapolated on the basis of that trial alone to what the behaviour of the trial agent will be in practice. The – those – that interpretation or that extrapolation is necessarily tentative if the trial is not very large or if there are other clinical trials on the same topic that have reliable evidence as well. In that case then all of the clinical trials should be taken together in the meta-analysis to determine whether the potential effect from one clinical trial is substantiated by other clinical trials. And if not, then the notion of the clinical effect of that one trial should be rejected…that’s the understood and gold standard process for evaluating clinical trials.

17    Her Honour concluded (at [41]):

Again, where a claim of a scientific nature is not based on a scientific study that demonstrates the claim and eminently qualified scientists reasonably hold contrary opinions about the potential for extrapolation from other studies to make the claim, their disagreement necessarily casts doubt on whether the claim is true or false.

18    From [42]-[111] the primary judge considered whether the Maxigesic advertisements conveyed the First and Second Representations. There is no challenge to her Honour’s finding that the advertisements did so and we need not summarise this part of the judgment.

The foundation for Maxigesic’s claim of superior pain relief

19    The primary judge then turned to consider whether Reckitt proved the absence of an adequate scientific foundation for AFT’s claims of Maxigesic’s superiority over other paracetamol/ibuprofen combination analgesics (at [112]). Her Honour noted that Reckitt relied on the following matters:

(1)    The absence of a clinical study that supports any representation of comparative superiority of Maxigesic over Nuromol either after single or multiple dosing.

(2)    The absence of any meta-analysis that compares the efficacy of Maxigesic and Nuromol.

(3)    The absence of any clinical study or meta-analysis that compares combination formulations of doses of ibuprofen and paracetamol in the quantities present in the commercial formulations of Maxigesic and Nuromol (at any dose).

(4)    The existence of only a single study to show any significant difference between 500mg paracetamol/200mg ibuprofen and 1000mg paracetamol/400mg ibuprofen, being the Mehlisch No. 1 study, which showed a difference only between 4 to 8 hours (single dose). That significance of that study is affected by the subsequent full study (Mehlisch No. 2 study), which found no statistically significant difference between 500mg paracetamol/200mg ibuprofen compared to 1000mg paracetamol/400mg ibuprofen as a single dose.

(5)    The Mehlisch No. 2 study and the Doherty study which, Reckitt submitted, permit no inference to be drawn as to the superiority of Maxigesic over Nuromol.

(6)    The relevant available meta-analyses (the Moore review and the Derry review), which disclose that there is no significant difference in efficacy between 500mg paracetamol/200mg ibuprofen and 1000mg paracetamol/400mg ibuprofen. Accordingly, Reckitt argued, no inference can possibly be drawn that two tablets of Maxigesic would be superior to one tablet of Nuromol.

20    AFT did not dispute the matters listed in (1) to (3) above. As the primary judge noted (at [114]) it submitted as follows:

AFT argued that the absence of a scientific study of the relative efficacy of Maxigesic and another combination analgesic does not demonstrate the falsity of the representations in the face of the following matters:

(1)    The dosing regimen for Maxigesic was approved by the Therapeutic Goods Administration (“TGA”) at the maximum approved daily dose for paracetamol and ibuprofen as monotherapies. It is inherently improbable that the TGA approved a higher dosing regimen for Maxigesic than other paracetamol/ibuprofen combinations if the higher dosing regimen has no additional effect.

(2)    Reckitt has sought and obtained regulatory approval in other countries for a dosing regimen of Nuromol at twice the approved levels in Australia. Further, its recommended single dose for Nurofen (ibuprofen) in Australia is 400mg. Reckitt’s own conduct is entirely inconsistent with the position it advances in this case. In effect, it admits the absurdity of that case.

(3)    Reckitt’s evidence does not establish a ceiling in the effectiveness of paracetamol and ibuprofen at the dosage of Nuromol (i.e., 500mg paracetamol/200mg ibuprofen single dose and 1500mg paracetamol/600mg ibuprofen daily dose).

(4)    There is adequate scientific evidence for the following propositions:

(a)    A combination of 1000mg paracetamol/400mg ibuprofen is a more effective dose than 500mg paracetamol/200mg ibuprofen.

(b)    A dose of 1000mg of paracetamol is more effective than a dose of 500mg of paracetamol.

(c)    A dose of 400mg of ibuprofen is more effective than lower doses of ibuprofen.

21    The reference to a “ceiling” (at (3) above) is a reference to Reckitt’s contention that there is an analgesic plateau or ceiling in paracetamol/ibuprofen combinations, at around the level of a single dose of Nuromol. If the existence of such a ceiling was established it would assist to show that the increased quantities of paracetamol and ibuprofen available through the use of Maxigesic would produce little or no increase in additional pain relief. Her Honour’s finding in relation to the existence of an analgesic ceiling is central in the appeal.

The scientific studies

22    The parties relied on numerous scientific studies concerning the efficacy of paracetamol and ibuprofen in combination, and also as monotherapies, being analgesic products which contain either paracetamol or ibuprofen as the single active pharmaceutical ingredient. Her Honour gave detailed attention to those studies and made a series of findings about them. While there is no challenge to those findings the appellant alleges that the primary judge erred in evaluating the scientific studies overall. It is therefore necessary to summarise her Honour’s findings.

The Daniels study (2011)

23    The primary judge considered this study at [116]-[121]. It assessed the efficacy of single doses of 1000mg paracetamol/400mg ibuprofen and 500mg paracetamol/200mg ibuprofen against 400mg ibuprofen/25.6mg codeine, 1000mg paracetamol/30mg codeine and placebo in a dental pain model of removal of at least three impacted teeth. The study concluded that one or two tablets of a single tablet combination of 500mg paracetamol/200mg ibuprofen “provided highly effective analgesia that was comparable with or superior to other combination analgesics marketed for strong pain.”

24    Her Honour found (at [121]) that (emphasis added):

…the Daniels study provides scientific evidence that a combination of 1000mg paracetamol/400mg ibuprofen is a more effective dose than 500mg paracetamol/200mg ibuprofen. It does not provide scientific evidence that a combination of 1000mg paracetamol/300mg ibuprofen (that is, a combination containing less ibuprofen) is a more effective dose than 500mg paracetamol/200mg ibuprofen, because it did not test that comparison.

25    Her Honour noted (at [127]) that the study did not however address the comparative efficacy of a single dose of Maxigesic (being 1000mg paracetamol/300mg ibuprofen) and a single dose of Nuromol (being 500mg paracetamol/200mg ibuprofen). A single dose of Maxigesic contains 100mg less ibuprofen than the combination tested.

The Doherty study (2011)

26    The primary judge considered this study at [122]-[127]. It examined the efficacy of three daily doses of 400mg ibuprofen, 1000mg paracetamol, 500mg paracetamol/200mg ibuprofen and 1000mg paracetamol/400mg ibuprofen in treating knee pain over both a 10 day and a 13 week period. It used a range of metrics including a visual-analogue pain scale, an arthritis pain scale and a patient assessment.

27    There was no dispute that the study found that 1000mg paracetamol/400mg ibuprofen was not statistically significantly more effective in providing pain relief than 500mg paracetamol/200mg ibuprofen. AFT argued however that the study results showed that 1000mg paracetamol/400mg ibuprofen was more effective than that 500mg paracetamol/200mg ibuprofen, but the results were “just shy” of statistical significance. AFT argued that it was inappropriate to disregard the study finding on the basis that they lacked statistical significance, and the Court should consider the results as supportive of the superiority of 1000mg paracetamol/400mg ibuprofen over 500mg paracetamol/200mg ibuprofen.

28    Her Honour found (at [127]) that the study provides scientific evidence that a combination of 1000mg paracetamol/400mg ibuprofen does not provide more effective pain relief than 500mg paracetamol/200mg ibuprofen where the difference in efficacy of those doses was found not to be of statistical significance. On the other hand, her Honour also accepted that the study provides scientific evidence of the superiority of 1000mg paracetamol/400mg ibuprofen over 500mg paracetamol/200mg ibuprofen, albeit evidence lacking statistical significance.

29    Her Honour noted that, like the Daniels study, the Doherty study did not address the comparative efficacy of a single dose of Maxigesic and a single dose of Nuromol.

The Mehlisch No. 1 study (2010)

30    The primary judge considered this study at [128]-[134]. It compared the pain relief provided by a single dose of paracetamol (1000mg and 500mg), a single dose of ibuprofen (400mg and 200mg) and combinations of 1000mg paracetamol/400mg ibuprofen and 500mg paracetamol/200mg ibuprofen. The study involved a cohort of 234 patients and its authors referred to it as a “pilot study” and as a “proof-of-concept study”. The authors noted that “doses of ibuprofen and paracetamol were selected to be at or near their analgesic ceiling in relation to their respective dose-response curves” (emphasis added).

31    Her Honour found that the study’s conclusions included that:

(1)    1000mg paracetamol/400mg ibuprofen provided significantly better mean pain relief than 500mg paracetamol/200mg ibuprofen …;

(2)    1000mg paracetamol/400mg ibuprofen was approximately 30% more effective than 500mg paracetamol/200mg ibuprofen;

(3)    1000mg paracetamol/400mg ibuprofen provided a higher peak mean pain relief score than 500mg paracetamol/200mg ibuprofen, which was significant at 4 hours;“[at] most time points, patients in the ibuprofen 400mg/paracetamol 1000mg group achieved significantly better mean PID [Pain Intensity Difference] scores than ibuprofen alone, paracetamol alone, and ibuprofen 200mg/paracetamol 500mg”;

(4)    1000mg paracetamol/400mg ibuprofen provided superior pain relief to 400mg ibuprofen alone whereas 500mg paracetamol/200mg ibuprofen did not.

32    The primary judge accepted Reckitt’s contention that the study found no difference in the efficacy of 1000mg paracetamol/400mg ibuprofen and the 500mg paracetamol/200mg ibuprofen combinations over the first four hours of use. Her Honour found (at [134]):

Accepting Reckitt’s qualifications set out above, the Mehlisch No. 1 study provides scientific evidence that a combination of 1000mg paracetamol/400mg ibuprofen is a more effective dose than 500mg paracetamol/200mg ibuprofen.

In the appeal AFT relies, in particular, on this study and the Daniels study.

The Mehlisch No. 2 study (2010)

33    The primary judge considered this study at [135]-[141]. The study described its objectives as being “a 2-stage clinical trial that was designed to confirm and extend the findings of the [Mehlisch No. 1 study] and to generate data for regulatory purposes”. It involved a substantially larger cohort than the Mehlisch No. 1 study; 735 patients were randomly assigned in stage one, 715 patients entered the study, and 678 patients completed stage two. The study report said that the objective of stage one was to compare the efficacy and tolerability of single tablet fixed dose combinations of paracetamol and ibuprofen being 250mg paracetamol/100mg ibuprofen, 500mg paracetamol/200mg ibuprofen and 1000mg paracetamol/400mg ibuprofen, with comparable doses of ibuprofen and paracetamol as monotherapies, and placebo. The objective of stage two was to compare the efficacy and tolerability of the same three doses of paracetamol/ibuprofen combinations with each other and with placebo over the 72 hour postoperative period following stage one.

34    The primary judge found (at [138]) that the study:

(a)    did not find a statistically significant difference in the efficacy of 1000mg paracetamol/400mg ibuprofen and 500mg paracetamol/200mg ibuprofen. This finding is significant to her Honour’s ultimate conclusion in relation to the adequacy of the scientific foundation for the representations. It is not challenged in the appeal; and

(b)    found that 1000mg paracetamol/400mg ibuprofen provided superior pain relief to 400mg ibuprofen alone, while 500mg paracetamol/200mg ibuprofen did not. AFT relied on this as showing that, notwithstanding the first finding, there was evidence of a dose response relationship above the level of a single dose of Nuromol.

35    The primary judge noted (at [140]) the evidence of Professor Rolan, a pain management physician who gave evidence for AFT, who said (emphasis added):

While the Mehlisch Study No 2 did not find the 1000 mg paracetamol/400 mg ibuprofen to be more effective than the 500 mg paracetamol/200 mg ibuprofen dose, I do not consider that this single study conclusively determines that there is a plateau at 500 mg paracetamol/200 mg ibuprofen. It is common in clinical research for trials comparing treatments not to produce the same result. Whether a difference exists between treatments needs to be determined on the overall balance of trials, hence the value of meta-analysis. There is substantial scientific evidence to the contrary as identified in my first affidavit and in this affidavit.

36    The primary judge found (at [141) (emphasis added):

Having regard to Professor Rolan’s evidence, the Mehlisch No. 2 study is:

(1)    scientific evidence that a combination of 1000mg paracetamol/400mg ibuprofen is not a more effective dose than 500mg paracetamol/200mg ibuprofen; and

(2)    scientific evidence of a ceiling in the effectiveness of paracetamol and ibuprofen at the dosage of Nuromol (i.e., 500mg paracetamol/200mg ibuprofen single dose).

Again, these findings are significant to her Honour’s ultimate conclusion in relation to the adequacy of the scientific foundation for the representations and they are not challenged in the appeal.

The Steiner study (2003)

37    The primary judge considered this study at [142]-[145]. It compared the pain relief provided to sufferers of tension type headache by a single dose of 500mg and 1000mg of aspirin or paracetamol as a monotherapy. The primary judge found that the study provides scientific evidence that a dose of 1000mg paracetamol is more effective than a dose of 500mg paracetamol.

The Schou study (1998)

38    The primary judge considered this study at [146]- [149]. It compared the pain relief provided by a single dose of 50mg, 100mg, 200mg or 400mg of ibuprofen as a monotherapy for patients having an impacted molar removed. Her Honour noted that the study showed a positive dose-response relationship between the doses tested, with 400mg ibuprofen providing maximum pain relief and the longest duration of analgesic effect.

The Cochrane reviews (2008-2015)

39    The primary judge considered four Cochrane reviews upon which the parties relied at [150]-[169]. Her Honour held that “Cochrane reviews are systematic reviews of primary research in health care and health policy”, and as “meta-analyses…[which] compare results from multiple clinical trials, and may increase power in statistics and results of the individual clinical trials”. Her Honour also held that such reviews are well regarded as one of the “gold standards” used for the translation of clinical practice in trials for evidence-based healthcare resources, and noted that Professor Rolan accepted that Cochrane reviews are “independent, high quality reliable sources of information comparing treatments”.

The Moore review (2015)

40    The primary judge considered the Moore review at [152]-[157]. It examined the results of earlier Cochrane reviews looking at the efficacy of different oral analgesics in the treatment of acute postoperative pain. In assessing the comparative efficacy the review used a metric named “NNT”. “NNT” is an acronym for a commonly used metric in clinical studies (at [159]). It stands for the number of patients who needed to be treated to produce one positive outcome, being a 50% reduction in one patient’s subjectively perceived pain levels over a four to six hour period.

41    Her Honour noted Reckitt’s submission that the review found that 1000mg paracetamol/400mg ibuprofen and 500mg paracetamol/200mg ibuprofen had almost the same NNT (1.5 versus 1.6) and “their confidence intervals nearly completely overlapped so that they did not significantly differ (or really differ at all in reality) – which evidences that their efficacy is not different” (at [153]).

42    AFT did not refute that the NNTs were similar but argued that the review showed that single doses of 1000mg paracetamol/400mg ibuprofen have a “slightly better” NNT and a longer duration of effect than single doses of 500mg paracetamol/200mg ibuprofen. In reliance on the evidence of Professor Rolan it also contended that there are limitations in the value of NNT as a metric for measuring comparative pain relief. The primary judge did not summarise the relevant part of Professor Rolan’s evidence, but in argument before us, AFT directed the Court’s attention to passages in his affidavit where he said that, while accepting that Cochrane Reviews are independent, high quality, reliable sources of information, the NNT metric has significant limitations because it is:

…a measure of the proportion of patients who experience a minimum outcome (50% reduction in pain). It does not provide any information about the maximum reduction in pain levels provided by a treatment, or the duration of that reduction in pain levels, which are the key considerations when assessing claims of relative “strength” of analgesics. While these characteristics may be correlated to the NNT of a treatment, that cannot be taken for granted.

(Emphasis in original)

43    The primary judge accepted Professor Rolan’s evidence concerning the limitations of the NNT metric, and found (at [157]) that the review was “inconclusive as to whether 1000mg paracetamol/400mg ibuprofen is more efficacious than 500mg paracetamol/200mg ibuprofen”.

The Rabbie review (2013)

44    The primary judge considered this review at [158]-[160]. It examined the results of studies assessing the efficacy of 200mg and 400mg doses (amongst others) of ibuprofen as a monotherapy in the treatment of migraine. Her Honour found that the review provides scientific evidence that 400mg ibuprofen provides more effective pain relief than 200mg ibuprofen.

The Derry Review (2009)

45    The primary judge considered this review at [161]-[166]. We note that her Honour incorrectly stated the date of this review as 2013 in the heading to this section of the primary judgment.

46    There were two Derry reviews before the Court, one published in 2009 and another in 2013. The primary judge’s reasons at [161]-[166] dealt with the Derry Review published in 2009; C. Derry et al, “Single dose oral ibuprofen for acute post-operative pain in adults” (2009) Cochrane Database of Systematic Reviews. As the title indicates, this review considered ibuprofen as a monotherapy.

47    The 2013 Derry review is C. Derry et al, “Single dose oral ibuprofen plus paracetamol (acetaminophen) for acute post-operative pain (Review)” (2013) Cochrane Database of Systematic Reviews. As the title indicates, it considered single doses of paracetamol/ibuprofen combinations.

48    In the appeal book the parties describe the 2009 review as the “Derry review” and the 2013 review as the “Derry review 2”. We take the same approach.

49    The primary judge noted that the Derry review assessed the analgesic efficacy of single doses of ibuprofen as a monotherapy for moderate and severe post-operative pain in adults. Her Honour said that the study found that “there was no significant difference in the NNT of 2.7 for 200mg of ibuprofen compared to the NNT of 2.5 for 400mg of ibuprofen.”

50    Professor Rolan again sought to discount the significance of the review on the basis that it used the NNT metric. The primary judge accepted Professor Rolan’s evidence as to the limitations of NNT as a metric for measuring comparative pain relief and found (at [166]) that the review was “inconclusive as to whether 400mg ibuprofen is more effective than 200mg ibuprofen”.

The Toms review (2008)

51    The primary judge considered this review at [167]-[169]. It assessed the efficacy of single dose paracetamol as a monotherapy for the treatment of acute post-operative pain. Her Honour noted at [168] that the review found:

…there was no significant difference in the NNT of 3.5 for 500mg of paracetamol compared to the NNT of 3.6 for 975 to 1000mg of paracetamol.

52    AFT accepted that the Toms review did not find a difference in the pain relief provided by the different doses of paracetamol, but argued that “[d]ose response may be more sensitively determined using trials that directly compare two doses, as has been done for paracetamol 100mg compared with 500mg”. In essence AFT argued that the authors of the study considered the different study design may have shown a dose response relationship between 500mg paracetamol and 1000mg paracetamol. In the appeal AFT does not challenge the finding that there is no significant difference in the NNT between the different doses.

TGA approval of the Maxigesic dosing regimen

53    The primary judge then considered the fact that the standard Maxigesic dose of 1000mg paracetamol/300mg ibuprofen was approved by the TGA (at [170]-[173]). It was not in dispute that the TGA would not have approved Maxigesic unless satisfied that it was effective and safe when used in accordance with the recommended maximum daily dose.

54    The primary judge held that in the absence of evidence as to the scientific material provided to or procured by the TGA, or evidence of the TGA’s processes of evaluation of Maxigesic and Nuromol or other paracetamol/ibuprofen combinations, the fact of TGA approval did not alone or in combination with other matters provide an answer to Reckitt’s case that there is no adequate scientific foundation for the representations (at [173]).

Reckitt’s dosing regimen for Nuromol in other countries and Nurofen in Australia

55    It was not in dispute before the primary judge, nor before us, that Reckitt has obtained approval for and marketed Nuromol in other countries in a single dose of 1000mg paracetamol/400mg ibuprofen (being twice its approved single dose in Australia), and has also obtained approval for and marketed Nurofen (its ibuprofen monotherapy) in Australia which contains a single dose of 400mg (which is twice the amount of ibuprofen as a single dose of Nuromol).

56    AFT contended that Reckitt’s case as to the falsity of the representation that Maxigesic provided superior pain relief was incompatible with its own conduct overseas and its recommended dose of Nurofen (at [177]-[181]). It relied on Professor Rolan’s evidence that “regulatory bodies around the world have accepted the claims that a 400mg dose of ibuprofen provides meaningfully better pain relief than a 200mg dose of ibuprofen” and also accepted “that there is not a ceiling on the effectiveness of ibuprofen at 200mg.” He said that Reckitt’s contention that there is an analgesic ceiling at 500mg paracetamol/200mg ibuprofen was inconsistent with its international approach to the marketing and regulatory approval of Nuromol.

57    The primary judge noted however that, apart from the scientific studies earlier considered, AFT did not identify the scientific foundation for the conduct of Reckitt that was said to be incompatible. Her Honour held that Reckitt’s dosing regimens for Nuromol overseas and Nurofen elsewhere could only justify AFT’s representations to the extent of the scientific foundation for those dosing regimens (at [179]). Her Honour did not accept that “facts concerning overseas regulatory approval demonstrate the superiority of a higher dose paracetamol/ibuprofen combination over a lower dose of the same combination in the absence of evidence that the relative benefits of the different doses are the subject of scientific evidence that was accepted by the regulatory authorities as a part of those processes.”

Whether or not an analgesic ceiling exists

58    Under this heading the primary judge considered the evidence and submissions as to whether a relevant analgesic ceiling exists (at [182]-[192]), noting AFT’s contention that Reckitt’s case appeared to rest on establishing that there is an analgesic ceiling at the level of the Nuromol dosing regimen, being a single dose of 500mg paracetamol/200mg ibuprofen and a maximum daily dose of 1500mg paracetamol/600mg ibuprofen. The primary judge did not accept that proposition. Her Honour said that, although Reckitt did argue that the evidence supports the existence of a relevant ceiling, she did not understand Reckitt to contend that it was necessary for it to establish such a ceiling in order to discharge its onus (at [184]).

59    The primary judge’s approach to the existence of an analgesic ceiling is central in the appeal.

60    Her Honour noted Reckitt’s contention that the following four matters established the existence of a relevant ceiling (at [185]):

(1)    The experts agreed that “there are insufficient data to determine whether Nuromol and Maxigesic have different maximal effect after single dose”.

(2)    The only two clinical studies to assess multiple doses of a paracetamol/ibuprofen combination were the Mehlisch No. 2 study and the Doherty study. Both of these studies found that there was no difference in efficacy between 500mg paracetamol/200mg ibuprofen and 1000mg paracetamol/400mg ibuprofen over multiple doses. Accordingly, Reckitt argued, no possible inference could be drawn from these studies that Maxigesic (having less APIs than two tablets of Nuromol) could be stronger or longer lasting than one tablet of Nuromol over multiple doses.

(3)    Professor Rolan accepted that the Mehlisch No. 2 study shows that there is no significant statistical difference in efficacy in Nuromol for the eight-hour period between 500mg paracetamol/200mg ibuprofen and 1000mg paracetamol/400mg ibuprofen.

(4)    The meta-analysis points to there being no difference between 500mg paracetamol/200mg ibuprofen and 1000mg paracetamol/400mg ibuprofen. The available Cochrane reviews provide no basis for any inference that Maxigesic is superior to Nuromol.

61    AFT relied on the evidence of Professor Christie in cross-examination to demonstrate that the ceiling for which Reckitt contended does not sit at the dosing levels of Nuromol. Her Honour noted his evidence was that there is a well-known plateau effect when treating pain with ibuprofen “at or extremely close to 200mg”, and that in some pain models, particularly dental pain, 400mg ibuprofen is more effective than 200mg. He agreed that, subject to any ceiling, an increase in the amount of the active pharmaceutical ingredients will produce stronger or better pain relief.

62    Professor Rolan dismissed Professor Christie’s evidence as to the existence of an analgesic ceiling partly on the basis that he provided no studies in support of the proposition that a ceiling is likely to be visible at a dose of 200mg ibuprofen. He noted that the Mehlisch No. 1 study found that the group treated with 1000mg paracetamol/400mg ibuprofen had significantly better mean pain scores compared with 500mg paracetamol/200mg ibuprofen, and that the Rabbie review demonstrated that 400mg ibuprofen provided better relief from migraine pain than 200mg ibuprofen.

63    The primary judge considered AFT’s contention that Professor Christie had not provided studies in support of his proposition to be just a debating point, as it was not put to him in cross examination that there were no such studies. Her Honour said that the Mehlisch No. 2 study and the Doherty study are relevant studies in support of the proposition that there is a relevant analgesic ceiling (at [189].

64    On the other hand, her Honour noted that Reckitt did not dispute that the Mehlisch No. 1 study and the Rabbie review are scientific evidence that there is no analgesic ceiling at 200mg ibuprofen (at [190]). Her Honour also noted that the Schou study observed a positive analgesic dose-response relationship between 200mg and 400mg doses of ibuprofen.

65    The primary judge then turned to consider further evidence of Professor Rolan in which he said that a single dose of two tablets of Maxigesic is “very likely to provide larger reductions in pain than a one tablet dose of Nuromol” and that there is insufficient evidence to establish a ceiling effect at 500 mg paracetamol or 200 mg ibuprofen, whether alone or in combination (at [191]).

66    In a finding which is central in the appeal the primary judge held (at [192]) (emphasis added):

… the evidence reveals that there is an unresolved question in the science as to the existence or otherwise of a relevant analgesic ceiling. I accept AFT’s submission that Reckitt has not established a ceiling for the analgesic effect of ibuprofen in combination with paracetamol at 500mg paracetamol/200mg ibuprofen. On the other hand, AFT has not established that there is no relevant ceiling.

The scientific evidence comparing other dosing regimens

67    Under this heading the primary judge said (at [193]):

AFT argued that the scientific evidence before the Court is sufficient to establish the following propositions:

(1)    There is adequate scientific support for the proposition that a combination of 1000mg paracetamol/400mg ibuprofen is a more effective dose than 500mg paracetamol/200mg ibuprofen (the Mehlisch No. 1 study and the Daniels study). The outcome of the Moore review and the Doherty study are also consistent with this proposition.

(2)    It can be accepted that the Mehlisch No. 2 study did not achieve the same results as the Mehlisch No. 1 study or the Daniels study. However, this does not advance Reckitt’s position in any meaningful way. No criticism is made by either party of the conduct of the Mehlisch No. 1 study or the Daniels study. They are both, notably, studies sponsored by Reckitt – it would be most surprising if Reckitt were heard to dismiss the validity of this study and the reliability of the results it achieved. They provide an adequate scientific foundation for the outcomes they report and that are not negated by the outcome of the Mehlisch No. 2 study.

(3)    There is adequate scientific support for the proposition that a dose of 1000mg of paracetamol is more effective than a dose of 500mg of paracetamol (the Steiner study).

(4)    There is adequate scientific support for the proposition that a dose of 400mg of ibuprofen is more effective than lower doses of ibuprofen (the Schou study and the Rabbie review).

AFT contended that it was appropriate to extrapolate from those propositions to conclude that Reckitt had not established the falsity of the impugned representations.

68    As to proposition (1), the primary judge accepted (at [195]) that:

(a)    the Mehlisch No. 1 study and the Daniels study provide scientific support for the proposition that a combination of 1000mg paracetamol/400mg ibuprofen is a more effective dose than 500mg paracetamol/200mg ibuprofen;

(b)    the Doherty study provides some scientific support for the proposition, although not to the level of statistical significance; and

(c)    the Moore review offers slight scientific support for the proposition.

69    As to proposition (2), the primary judge found (at (196]) (emphasis added):

…the Mehlisch No. 2 study did not achieve the same results as the Mehlisch No. 1 study or the Daniels study. They provide an adequate scientific foundation for the outcomes they report. However, in considering whether they provide an adequate scientific foundation for the representations, it is not appropriate to ignore the Mehlisch No. 2 study. That study casts doubt on whether the Mehlisch No. 1 study and the Daniels study provide an adequate scientific foundation for the representations because it provides evidence that there is no statistically significant difference between 500mg paracetamol/200mg ibuprofen and 1000mg paracetamol/400mg ibuprofen. To that extent, the Mehlisch No. 2 study does advance Reckitt’s case.

70    As to proposition (3), the primary judge found that the Steiner study provides scientific support for the proposition that a dose of 1000mg of paracetamol is more effective than a dose of 500mg of paracetamol (at [197]).

71    As to proposition (4), the primary judge accepted that the Schou study and the Rabbie review provide scientific support for the proposition that a dose of 400mg of ibuprofen is more effective than lower doses of ibuprofen (at [198]).

The primary judge’s consideration and conclusion

72    The primary judge noted that Professor Christie and Professor Rolan offered competing scientific opinions as to whether the representations had an adequate foundation in science. Her Honour said (at [202]):

It is not necessary to decide which of these opinions is more persuasive, because the issue for determination is whether there is an adequate scientific foundation for the relevant representations of fact.

73    The primary judge concluded that there is no adequate scientific foundation for the representations for the following seven reasons (at [203]):

(1)    There is no clinical study or meta-analysis which supports the representations by a trial of the comparative pain relief provided by Maxigesic and Nuromol or comparable doses of paracetamol/ibuprofen combinations.

(2)    The experts agreed that “there are insufficient data to determine whether Nuromol and Maxigesic have different maximal effect after single dose”.

(3)    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.

(4)    In particular, the Mehlisch No. 2 study is a significant part of the body of scientific knowledge concerning the truth or otherwise of the representations. That study, albeit involving a comparison of 1000mg paracetamol/400mg ibuprofen and 500mg paracetamol/200mg ibuprofen doses, tends to suggest that the representations may be false.

(5)    The Moore and Derry reviews also cast doubt on the truthfulness of the representations, because they indicate that the science is inconclusive as to the whether 1000mg paracetamol/400mg ibuprofen is more efficacious than 500mg paracetamol/200mg ibuprofen; and whether 400mg ibuprofen is more efficacious than 200mg ibuprofen.

(6)    I do not accept that the Mehlisch No. 1 study provides an adequate foundation for the representations in the light of the Mehlisch No. 2 study, and the Moore and Derry reviews.

(7)    Contrary to the opinion of Professor Rolan, I do not accept that significant weight can be placed on overseas regulatory approvals in the absence of evidence about the basis for those approvals.

This paragraph is central in the appeal and, although AFT does not challenge the underlying findings about the scientific studies, it attacks each part of her Honour’s reasoning.

74    Having concluded that there is not an adequate scientific foundation for the representations, her Honour found that by publishing the Maxigesic advertisements AFT made representations which were misleading or deceptive or likely to mislead or deceive, false or misleading, or liable to mislead in contravention of ss 18, 29(1)(a) and (g) and 33 of the ACL (at [204]-[205]).

THE APPEAL

75    The notice of appeal alleges as follows:

1.    Having correctly identified the applicable test as being whether there was no scientific foundation for the first Maxigesic representation and the second Maxigesic representation having regard to the balance of the available scientific evidence (see Primary Judgment, [7], [29], [30], [33], [35] and [36]), the Primary Judge erred in finding (at Primary Judgment, [13], [14], [203] – [205]) that there was not an adequate scientific foundation for those representations and, consequently, erred in finding that the Appellant had:

(a)    made misleading or deceptive representations, or representations which were likely to mislead or deceive, in contravention of s 18 of the Australian Consumer Law (ACL);

(b)    made misleading representations in contravention of ss 29(1)(a) and (g) of the ACL; and

(c)    made representations that were liable to mislead in contravention of s 33 of ACL.

2.    Having regard to the balance of the available scientific evidence, the Primary Judge erred at Primary Judgment, [203(1)]) in upholding the Respondent’s case in respect of the first Maxigesic representation and the second Maxigesic representation on the basis that there was no study or meta-analysis which provided a direct comparison of the competing products.

3.    Having correctly identified that the onus of making out a case in respect of the first Maxigesic representation and the second Maxigesic representation lay with the Respondent (see Primary Judgment, [30] and [33]), the Primary Judge erred (at Primary Judgment, [192] and [203(3)]) by imposing an onus on the Appellant to establish the existence and level of any ceiling in the effective doses of paracetamol and ibuprofen.

4.    Having correctly identified that:

(a)    the onus of making out a case in respect of the first Maxigesic representation and the second Maxigesic representation lay with the Respondent (see Primary Judgment, [30] and [33]); and

(b)    the applicable test as being whether there was no scientific foundation for the first Maxigesic representation and the second Maxigesic representation having regard to the balance of the available scientific evidence (see Primary Judgment, [7], [29], [30], [33], [35] and [36],

the Primary Judge erred (at Primary Judgment, [203(3) – (5)]) in upholding the Respondent’s case in respect of those representations on the basis that:

(i)    the evidence as to the absence of a relevant analgesic ceiling “is not so conclusive”;

(ii)    the Mehlisch No 2 Study “tends to suggest” that those representations may be false; and

(iii)    the Moore and Derry Reviews “cast doubt on the truthfulness of the representations”.

76    Ground one is supported by detailed references to the evidence:

(a)    particulars (i) to (vi) largely restate those of the primary judge’s findings about the scientific studies which favour AFT’s position, about which there is no challenge and which are captured in AFT’s submissions which we have set out;

(b)    particular (vii) alleges that the primary judge accepted but failed to give any or sufficient weight to the fact that Reckitt sought and obtained regulatory approval for a different dosing regimen for Nuromol overseas, and for Nurofen in Australia. The dosing regimens for Nuromol overseas and Nurofen in Australia are not in dispute; and

(c)    particular (vii) merely restates the overarching allegation that the primary judge erred in the assessment of the evidence.

77    The grounds of appeal are interrelated and it is appropriate to deal with them together.

AFT’S SUBMISSIONS

The alleged misapplication of the applicable test

78    AFT accepts that the learned primary judge correctly identified the relevant test as being whether, on the balance of probabilities, there is no adequate scientific foundation for the representations having regard to the available body of scientific evidence. It accepts that the test implicitly recognises that the Court may be asked to assess and balance competing scientific evidence and views.

79    AFT relies on the Macquarie Dictionary definition of ‘adequate’ as “equal to the requirement or occasion; fully sufficient, suitable or fit” and the Shorter Oxford English Dictionary definition as “commensurate in fitness; sufficient, satisfactory”. It argues that ‘adequate’ does not mean “incontrovertible, definitive or unopposed”, and that the concept of an “adequate scientific foundation” does not require that there be absolute scientific certainty or preclude the existence of competing scientific information or views.

80    It contends that the primary judge was therefore required to decide whether Reckitt established on the balance of probabilities that having regard to the scientific evidence before the Court, there is no adequate (that is, “sufficient”, “suitable”, “satisfactory”) scientific basis for the representations.

81    AFT contends that the primary judge erred in the application of the legal test and the onus in the following three broad ways:

(1)    The scientific evidence upon which the primary judge relied to found the conclusion that there is no adequate scientific foundation for the representations, merely raised the possibility that the representations were false. Amongst other things there was insufficient evidence to determine whether there is an analgesic ceiling in the effective dose of paracetamol/ibuprofen combinations and, if so, the dose level of which that ceiling occurs. On a proper application of the legal test, the evidence was insufficient to found the primary judge’s conclusion;

(2)    The primary judge should instead have found that the scientific evidence comfortably provided an adequate scientific foundation for the representations; and

(3)    The primary judge misapplied the onus. Reckitt’s onus to show that there is no adequate scientific foundation for the impugned representations could not be discharged on the basis of the primary judge’s finding that there was insufficient evidence to determine the existence of, and the level of, any analgesic ceiling. The onus could not be discharged by evidence which merely “raised a possibility of falsity”.

82    AFT submits that there was a substantial body of scientific literature before the primary judge which provided strong support for there being an adequate scientific foundation for the impugned representations, including scientific studies which provided scientific evidence of a dose response, that is, increased efficacy, at doses over 500mg paracetamol/200mg ibuprofen which is the level of a single dose of Nuromol.

83    It relies on scientific studies in relation to paracetamol/ibuprofen combinations as providing evidence of a dose response, namely:

(a)    the Daniels study which provides evidence that a combination of 1000mg paracetamol/400mg ibuprofen is a more effective dose than 500mg paracetamol/200mg ibuprofen;

(b)    the Mehlisch No.1 study which provides evidence that a combination of1000mg paracetamol/400mg ibuprofen is more effective dose than 500mg paracetamol/200mg ibuprofen;

(c)    the Mehlisch No. 2 study which provides evidence for a dose response over 500mg paracetamol/200mg ibuprofen in finding that 1000mg paracetamol/400mg ibuprofen provided more effective pain relief than 400mg ibuprofen but that 500mg paracetamol/200mg ibuprofen did not; and

(d)    the Doherty study which provides evidence of the superiority of 1000mg paracetamol/400mg ibuprofen over 500mg paracetamol/200mg ibuprofen (albeit evidence lacking statistical significance), and also found that 1000mg paracetamol/400mg ibuprofen was more effective than 1000mg of paracetamol but that 500mg paracetamol/200mg ibuprofen was not.

84    AFT also argues that the scientific studies in relation to monotherapies provide further evidence for increased efficacy at doses over 500mg paracetamol/200mg ibuprofen, namely:

(a)    the Steiner study which provides evidence that a dose of 1000mg paracetamol is more effective than a dose of 500mg paracetamol;

(b)    the Schou study which found that a dose of 400mg ibuprofen provides greater and longer lasting pain relief than lower doses of 50mg, 100mg and 200mg of ibuprofen; and

(c)    the Rabbie review which provides evidence that 400mg of ibuprofen is more effective than 200mg of ibuprofen.

85    It also contends that the Moore review and the Derry review 2 support its case, in that:

(a)    the Moore review found that 1000mg paracetamol/400mg ibuprofen provided a longer duration of analgesia than 500mg paracetamol/200mg ibuprofen; and

(b)    the Derry review 2 demonstrates that 1000mg paracetamol/400mg ibuprofen provided superior pain relief than 500mg paracetamol/200mg ibuprofen.

AFT accepts however that neither of these reviews identify whether or not the results achieved statistical significance.

86    AFT also relies upon the fact that the primary judge found that Reckitt did not establish that there is a ceiling in the effective dose for paracetamol/ibuprofen combinations at 500mg paracetamol/200mg ibuprofen.

87    AFT accepts that there is scientific evidence which is at odds with its position but it argues that evidence was inconclusive or insufficient to provide a foundation for the primary judge’s conclusion and was substantially outweighed by the evidence supporting its position. It submits that the primary judge subjugated the substantial body of scientific evidence which favoured AFT’s position to the much less substantial and inconclusive body of scientific evidence upon which Reckitt relied.

88    AFT argues that the primary judge relied upon the outcomes of three Cochrane reviews: the Moore review, the Derry review and the Toms review; and the outcome of one clinical study, the Mehlisch No. 2 study, to support her conclusion that there was not an adequate scientific foundation for the representations. It notes that her Honour found that:

(a)    the Moore review is inconclusive as to whether 1000mg paracetamol/400mg ibuprofen is more efficacious than 500mg paracetamol/200mg ibuprofen (at [157]);

(b)    the Derry review is inconclusive as to whether 400mg ibuprofen is more effective than 200mg ibuprofen (at [166]);

(c)    the Toms review found that no significant difference in the NNT of 3.5 for 500mg of paracetamol compared to NNT of 3.6 for 975 to 1000mg of paracetamol (at [168]) and

(d)    the Mehlisch No. 2 study did not find a statistically significant difference between 1000mg paracetamol/400mg ibuprofen and 500mg paracetamol/200mg ibuprofen, but found that 1000mg paracetamol/400mg ibuprofen was superior to 400mg ibuprofen and 500mg paracetamol/200mg ibuprofen was not.

89    AFT contends that Professor Rolan’s evidence shows that the NNT metric has significant limitations as it is insensitive for measuring comparative pain relief, only informs how many patients must be treated before one patient obtains a minimum amount of relief, and does not give information on the maximal effect of the dose or the duration of its effect.

90    It also argues that of the three studies which directly tested 500mg paracetamol/200mg ibuprofen against 1000mg paracetamol/400mg ibuprofen in the dental pain model (being the Daniels study, the Mehlisch No. 1 study and the Mehlisch No. 2 study):

(a)    the first two studies demonstrated a dose response above the dosing regimen of Nuromol; and

(b)    while the Mehlisch No. 2 study did not find a statistically significant difference in comparative efficacy between those doses, it nonetheless found that 1000mg paracetamol/400mg ibuprofen was more effective than 400mg ibuprofen whereas 500mg paracetamol/200mg ibuprofen was not.

91    AFT further contends that the results of the Moore review and the Derry review 2 supported the representations but the primary judge found that they were inconclusive as they did not include a statistical analysis. It argues that such a finding does not mean that there was no adequate scientific foundation for the representations.

92    In relation to the Toms review, the Derry review and the Mehlisch No. 2 study, AFT submits that the primary judge placed undue reliance on the outcomes of those studies. It argues that they were not consistent with the main body of scientific evidence relied upon by AFT which was broader, deeper and outweighed that material.

93    AFT further argues that, before us, Reckitt wrongly emphasises phrases in RB v GSK at [41] such as, “the balance of the scientific evidence demonstrated no clear-cut superiority of ibuprofen over paracetamol” and “the overall conclusion to be drawn from the scientific evidence was that no authoritative comparisons between active treatments were possible in the then state of scientific knowledge”. It submits that in doing so Reckitt misidentified the role of those phrases in that decision. It says that the Full Court was not reformulating or replacing the established test of whether there is no adequate scientific foundation for a representation. Rather, the Full Court was making statements about the state and balance of the scientific evidence in that case, in which Reckitt was unsuccessful at first instance and on appeal because its position depended on one outlier study which was inconsistent with the overall body of scientific evidence. It argues that position stands in sharp contrast with the present case where AFT relied below upon a substantial body of scientific evidence.

The alleged misapplication of the onus of proof

94    AFT accepts that the primary judge correctly identified that Reckitt bore the onus, but contends that her Honour’s reasoning shows that she misapplied it.

95    As we have said, AFT argued below that Reckitt’s case “appeared to rest” upon it establishing a relevant analgesic ceiling (although the primary judge did not accept that for Reckitt to discharge its onus it was necessary for it to do so).

96    Ultimately, the primary judge found that Reckitt failed to establish the existence of an analgesic ceiling at the level of 500mg paracetamol/200mg ibuprofen, and also that AFT did not establish that there is no relevant ceiling (at [192]). Her Honour held that “there is an unresolved question in the science as to the existence or otherwise of a relevant analgesic ceiling”.

97    AFT argues that the findings at [192] are important when considering where the onus lay. It notes that at their respective recommended maximum daily doses Maxigesic contains 2500mg more paracetamol and 600mg more ibuprofen than Nuromol and contends that, absent a ceiling, it is logical that Maxigesic provides more effective pain relief than paracetamol/ibuprofen combinations such as Nuromol, which have significantly lower quantities of the active pharmaceutical ingredients. It also submits the absence of a ceiling is consistent with the evidence of both Professor Rolan and Professor Christie, some of which evidence the primary judge referred to at [186]-[191]. In addition to that, AFT relies upon passages in the cross examination of Professor Christie which it contends support the conclusion that no ceiling exists at the level contended for by Reckitt. It submits that Professor Christie accepted that there is not a ceiling at the level of the dosing regimen of Nuromol, and that absent a ceiling the higher dose of paracetamol and ibuprofen (as found in Maxigesic) would provide more effective pain relief.

98    AFT contends that the scientific studies went no further than raising the possibility that there is no adequate scientific foundation for the representations and could not discharge Reckitt’s onus to establish their falsity. Relatedly it contends that the onus could not be discharged on the basis of the primary judge’s finding (at [192]) that there is an unresolved question in the science as to the existence of a relevant analgesic ceiling. AFT further argues that as a matter of logic the absence of evidence as to the existence of a ceiling cannot establish on the balance of probabilities the falsity of the representations.

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.

Associate:

Dated:    18 March 2020