Reckitt Benckiser (Australia) Pty Ltd v GlaxoSmithKline Australia Pty Ltd

1. The appeal be dismissed.
2. The parties have leave to file submissions on costs to be determined on the papers. Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

Introduction and background 1 The primary judge found that, by publishing certain advertising material, the appellant, Reckitt Benckiser (Australia) Pty Ltd (Reckitt) engaged in conduct that was misleading or deceptive, or likely to mislead or deceive, in contravention of s 18 of the Australian Consumer Law (ACL) and made false representations in contravention of ss 29(1)(a) and (g) thereof. 2 The advertising material comprised print advertising (including in store advertising) and a television commercial used in a comparative advertising campaign in which Reckitt compared its product Nurofen and its active ingredient ibuprofen with a competing product, Panadol and its active ingredient paracetamol (also called acetaminophen). The respondents, GlaxoSmithKline Australia Pty Ltd and GlaxoSmithKline Consumer Healthcare Australia Pty Ltd (Glaxo), are the suppliers of the competing product. 3 The primary judge found that representations to the following effect were made: (a) Nurofen, and thus ibuprofen, when taken in the recommended dose and as directed by the manufacturer, generally delivers faster and more effective relief from pain caused by common headaches including tension-type headaches (TTH) than Panadol or paracetamol. (b) For the reasons stated in (a), Nurofen is better than Panadol and paracetamol for the treatment of common headaches including TTH and performs in a superior manner to Panadol and paracetamol in delivering pain relief for such headaches. (c) At the time when Reckitt conducted its comparative advertising campaign (August to December 2015), there was a current adequate foundation in scientific knowledge to support the representations set out in (a) and (b). 4 These are not the precise representations formulated by Glaxo in its Amended Fast Track Statement dated 15 October 2015, and accepted by Reckitt in its Fast Track Response dated 22 October 2015. However, the parties take no issue with the primary judge's summation. 5 The parties accepted before the primary judge that the question to be decided was whether the claims made in the comparative advertising campaign could be supported by an adequate foundation in scientific knowledge current throughout the period August to December 2015. 6 Reckitt argued that there was an adequate foundation. It relied on the results of a study published as Schachtel BP, Furey SA, and Thoden WR, Non prescription Ibuprofen and Acetaminophen in the Treatment of Tension­Type Headache (1996) 36 J Clin Pharmacol 1120-1125 (the Schachtel Study). The Schachtel Study is a report on a clinical trial conducted in 1996 which concluded: The results of this study demonstrate that both ibuprofen at 400 mg and acetaminophen at 1000 mg are effective in the treatment of muscle contraction headache and that a single dose of ibuprofen at 400 mg is significantly more effective than acetaminophen at 1000 mg in the treatment of muscle contraction headache. 7 Glaxo accepted that the Schachtel Study was a properly designed and properly conducted clinical trial. The expert witness engaged by Glaxo - Professor Somogyi - and the expert witness engaged by Reckitt - Professor Dworkin - agreed that the Schachtel Study provided: … convincing evidence for the superiority of ibuprofen 400 mg over paracetamol 1,000 mg in TTH, with differences that can be considered clinically meaningful. 8 Reckitt also relied on the fact that no other clinical trial proved the opposite of the results reported in the Schachtel Study or put those results in doubt. It further relied on its success before two panels of the Australian Self Medication Industry, which rejected the substance of Glaxo's present complaints in 2014. 9 For its part, Glaxo relied on other scientific evidence, namely two clinical trials referred to by the primary judge as Study NL9701 and the NCT Study, and certain meta-analyses, namely Moore RA et al "Evidence for Efficacy of Acute Treatment of Episodic Tension-Type Headache: Methodological Critique of Randomised Trials for Oral Treatments" (2014, 155 Pain 2220) (the Moore Study) and two analyses undertaken by Cochrane et al in 2015 and 2016 (Cochrane 2015 and Cochrane 2016, respectively). A meta-analysis is a review which pools data across all available studies to report an outcome based on all those studies. Professor Somogyi gave evidence that this process minimises the weight placed on one particular study and gives appropriate weighting to all appropriate available data. Professor Dworkin agreed that, because they synthesise the results from all relevant studies, well-conducted meta-analyses are generally more informative than single clinical trials. He also agreed with Professor Somogyi that, in general, the Cochrane systematic reviews and meta-analyses are a gold standard for evaluating and comparing medical efficacy and safety. 10 Study NL9701 was commissioned by Boots Healthcare International (Boots) (which was later subsumed into Reckitt). The objectives of the study were stated as follows: The primary objective of this study was to evaluate the analgesic effectiveness at 4 hours after administration of ibuprofen (Nurofen™) 400mg compared with commercially available paracetamol 1000mg and placebo for the treatment of tension-type headache. In addition, the study aimed to evaluate the analgesic effectiveness at 2 and 6 hours after administration, the recurrence rate of headache during the 24-hour period of dosing and the incidence and severity of adverse events associated with these three treatment regimens. 11 Professor Somogyi and Professor Dworkin agreed that Study NL9701 was well-designed, properly conducted and robust. 12 The primary judge recorded the study's conclusion as follows: There were no statistically significant differences between ibuprofen 400mg and paracetamol 1000mg, although a slight trend in favour of paracetamol was observed in the majority of efficacy parameters. 13 At [186], the primary judge concluded: It was common ground and I find that Study NL9701 did not replicate the results of the Schachtel Study. On the other hand, Glaxo accepted and I also find that the results of Study NL9701 did not invalidate or impugn the results of the Schachtel Study. As Glaxo submitted, the results of Study NL9701 cannot be set aside or discounted. In any consideration or assessment of the relevant state of knowledge in science as at August 2015, the existence of Study NL9701 and the conclusion reached by the authors of that study need to be taken into account. 14 Study NL9701 was not published. The primary judge found that the decision not to publish was made by either Reckitt or Boots. 15 The NCT Study was conducted by Glaxo in relation to the treatment of episodic TTH comparing placebo, paracetamol plus caffeine, a marketed formulation of paracetamol, and a marketed formulation of ibuprofen. The study was terminated apparently due to "unforeseen difficulties with subject recruitment". The primary judge found that the NCT Study did not support the results of the Schachtel Study. However, as was the case with Study NL9701, it did not support the opposite proposition either. 16 The Moore Study is a meta-analysis that was in existence and known to Reckitt when it commenced its comparative advertising campaign. The study included the Schachtel Study and Study NL9701. 17 The primary judge recorded the result of the Moore Study as follows: It was possible to pool data from trials for some drugs (paracetamol 1000mg, ibuprofen 400mg, ketoprofen 25mg and aspirin 1000mg) for some of these three outcomes. Table 3 shows the amount of data available for pooling, the mean event rates, and risk ratio and NNT's calculated by pooling. There was little difference among the drugs, and NNT's were high, at about 9, for the IHS-preferred outcome of pain-free at two hours. 18 Professor Dworkin acknowledged that the results of the Moore Study did not support a difference between ibuprofen and paracetamol at the 2 hour pain-free endpoint. 19 The meta-analysis referred to by the primary judge as Cochrane 2015 (Derry S, Wiffen PJ, Moore RA, Bendtsen L Ibuprofen for acute treatment of episodic tension-type headache in adults The Cochrane Database of Systematic Reviews 2015, Issue 7. Art. No.: CD011474. DOI: 10.1002/14651858. CD011474.pub2.) was part of the body of scientific knowledge known as at August 2015. The Cochrane Collaboration is a not-for-profit organisation that carries out systematic reviews of healthcare interventions. The reviews are deposited in a database and are used as a reference source, including by health authorities such as, in Australia, the Pharmaceutical Benefits Advisory Committee. 20 Cochrane 2015 was based on 12 studies, including the Schachtel Study and Study NL9701. The authors concluded: While ibuprofen 400 mg is one choice for treatment of episodic TTH, it may be that higher doses or different formulations might be better, but evidence on this is lacking. Ibuprofen 400 mg is probably not much different from any other treatment, based on what is known. 21 In comparing active treatments, the authors concluded: No authoritative comparisons between active treatments is possible in the present state of knowledge. 22 Cochrane 2016 (Stephens G, Derry S, Moore RA, Paracetamol (acetaminophen) for acute treatment of episodic tension-type headache in adults Cochrane Database of Systematic Reviews 2016, Issue 6. No.: CD011889. DOI: 10.1002/1465858.CD011889.pub2) was based on 23 studies, including the Schachtel Study, Study NL9701 and the NCT Study. The primary judge referred to Cochrane 2016 even though it was not part of the body of scientific knowledge available as at August 2015. It seems that his Honour did so for completeness - Cochrane 2016 having been introduced into evidence via an affidavit made by Professor Dworkin. 23 With regard to the comparison between paracetamol and ibuprofen, the authors in Cochrane 2016 concluded: … Based on very limited information, there was no difference between paracetamol and ibuprofen for pain free at two hours (low quality evidence), but a statistical difference was found for pain free at four hours (very low quality evidence). 24 As in Cochrane 2015, the authors concluded: No authoritative comparisons between active treatments is possible in the present state of knowledge. 25 Before the primary judge, Glaxo submitted that, given the various studies forming part of the body of scientific knowledge known as at August 2015 - which do not speak with one voice - Reckitt's conduct in simply citing and reproducing the Schachtel Study in support of the representations it had made was misleading or deceptive or likely to mislead or deceive. It also submitted that the representations were false. 26 Reckitt submitted that it was not misleading or false to conduct its campaign in the way it did because the Schachtel Study provided support for its claims and no other study, whether a clinical trial or meta-analysis, suggested that the results of the Schachtel Study were invalid or unsupportable. 27 The primary judge accepted Glaxo's submission: In my view, it is misleading or deceptive or likely to mislead or deceive consumers in Australia for Reckitt to claim that ibuprofen (Nurofen) provides faster and more effective relief from pain caused by common headaches including TTH than does paracetamol (Panadol) when the only study which supports such a clear cut claim is the Schachtel Study and where the balance of the scientific knowledge is as I have explained it above. By making such representations, Reckitt also contravened s 29(1)(a) and s 29(1)(g) of the ACL. 28 The primary judge rejected Reckitt's submission, saying: … I think that that is too simplistic a view of the relevant body of scientific knowledge. Study NL9701 and the NCT Study did not replicate the Schachtel Study results and the meta-analyses, after appropriate weighting and application of systematic review principles, did not support the results of the Schachtel Study. The Cochrane meta-analyses concluded that no claim of superiority could justifiably be made by ibuprofen over paracetamol in the present state of scientific knowledge.