GlaxoSmithKline Australia Pty Ltd v Reckitt Benckiser

Federal Court of Australia|2018-01-08|Before: Foster J

Introduction 136 The representations which I have distilled from the advertisements and promotional materials and set out at [135] above are representations of past and present fact. In addition, as already noted at [53] and [54] above, a number of judges in this Court have held that representations of this type, in particular when made in respect of certain specified therapeutic qualities of substances or products, are also representations with respect to future matters. That is, when claims of this type are made, the representor is regarded as stating to those to whom the representations are made: "If you take this substance or use this product as directed you will gain the benefits claimed". Here, the claims are that, if consumers take Nurofen as directed, they will obtain relief from the pain which they may be suffering from a common headache, faster and more effectively than they would experience if they took Panadol or paracetamol instead. 137 Because Glaxo argued that the representations which I have set out at [135] above were also made with respect to future matters, it relied upon s 4 of the ACL. By making this submission, Glaxo sought to avail itself of the evidentiary advantages provided to an applicant by that section. In SPAR Licensing Pty Ltd v MIS Qld Pty Ltd (2014) 314 ALR 35 at 54-57 [67]-[74], I explained the import of s 51A of the Trade Practices Act 1974 (Cth) which more or less covered the same ground as s 4 of the ACL. It is an evidentiary provision only and does not reverse the legal or persuasive burden which the applicant bears of establishing that reasonable grounds for making the representations did not exist (see also Crowley v WorleyParsons Ltd [2017] FCA 3 at [71]). 138 Here, Reckitt claims that it had reasonable grounds for making the representations which I have found it made because the Schachtel Study supported the representations set out at subpars (a) and (b) of [135] above and constituted the necessary current foundation in scientific knowledge claimed by it thus establishing that the representation set out at subpar (c) of [135] above was true at the time when it was made. 139 Insofar as the representations which I have set out at [135] above constitute representations of past and present fact, Glaxo must prove that each representation was false or misleading or deceptive or likely to mislead or deceive at the time when it was made. Insofar as those representations were made with respect to future matters, Glaxo must prove that Reckitt did not have reasonable grounds for making those representations at the time when they were made ie throughout the period from early August 2015 to 15 December 2015. In the present case, both parties agree that the question of whether the requisite reasonable grounds existed for the representations will be decided by the answer to a further question, namely, whether the claims made in the campaign can be supported by an adequate foundation in scientific knowledge current throughout that period. In this regard, Reckitt relied upon the results of the Schachtel Study, the fact that no other clinical trial proved the opposite of those results or put those results in doubt and its success before the ASMI panels. 140 I think that this material was sufficient to satisfy the requirements of s 4 of the ACL so that the ultimate onus of proving the absence of reasonable grounds remained with Glaxo unaided by the presumptions referred to in s 4 of the ACL. Glaxo relied upon much the same scientific materials as were relied upon by Reckitt in order to establish its ultimate proposition - absence of reasonable grounds. Glaxo sought to place a very different interpretation upon those materials based upon the evidence of Professor Somogyi. 141 Glaxo makes an additional criticism of the impugned advertisements. It contends that ibuprofen and thus Nurofen is not suitable for consumption by all or practically all consumers looking for relief from pain caused by common headaches. Glaxo claims that this fact is not made clear in the impugned advertisements and that, for this reason, the advertisements are misleading or deceptive or likely to mislead or deceive. 142 Reckitt accepted that ibuprofen and thus Nurofen might not be suitable for all or practically all consumers with headache pain. However, it points to the material at the bottom of the advertisements which, it submitted, makes clear that Nurofen should only be taken as directed and that incorrect use could be harmful. It went on to submit that directions on the Nurofen packaging make perfectly plain that it may not be suitable for all or practically all consumers seeking relief from pain caused by common headaches. 143 In my view, the representations are qualified by the broad caution that Nurofen should be taken only as directed. Those consumers who may not be suitable as consumers of Nurofen for good reason as indicated on Nurofen packaging are not encouraged to purchase Nurofen come what may. Therefore, I do not think that Glaxo has made good its proposition as pleaded in par 15A of the AFTS.

The Relevant Science 144 The body of scientific knowledge current when the impugned advertising and promotional activity took place (August to December 2015) may be summarised as follows: A single clinical study which was conducted in 1996 and which established statistically significant superiority in terms of speed and efficacy of treatment for ibuprofen over paracetamol. This is the Schachtel Study. The conclusion of that study was expressed in the following terms: 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. 145 This conclusion was plotted on a graph (Figure 2) in the study. That graph is reproduced at [178] below. 146 I shall return to the Schachtel Study in a little more detail later in these Reasons. 147 These results were not replicated in two further studies designed to compare the speed and efficacy of treatment as between ibuprofen and paracetamol with respect to pain free relief at two hours after dosage. The studies relevant to this last proposition are Study NL9701 and the NCT Study (NCT01755702). Meta-analyses carried out subsequently by reputable scientists (Professor Moore and others in 2014 and Cochrane and others in 2015 and 2016) concluded that there is no basis in the science for supporting the alleged superiority of ibuprofen over paracetamol as suggested by the Schachtel Study. 148 As already mentioned, in respect of its case based upon the representations having been made with respect to future matters, Glaxo pleads and relies upon s 4 of the ACL. Section 4 of the ACL is in the following terms: 4 Misleading representations with respect to future matters (1) If: (a) a person makes a representation with respect to any future matter (including the doing of, or the refusing to do, any act); and (b) the person does not have reasonable grounds for making the representation; the representation is taken, for the purposes of this Schedule, to be misleading. (2) For the purposes of applying subsection (1) in relation to a proceeding concerning a representation made with respect to a future matter by: (a) a party to the proceeding; or (b) any other person; the party or other person is taken not to have had reasonable grounds for making the representation, unless evidence is adduced to the contrary. (3) To avoid doubt, subsection (2) does not: (a) have the effect that, merely because such evidence to the contrary is adduced, the person who made the representation is taken to have had reasonable grounds for making the representation; or (b) have the effect of placing on any person an onus of proving that the person who made the representation had reasonable grounds for making the representation. (4) Subsection (1) does not limit by implication the meaning of a reference in this Schedule to: (a) a misleading representation; or (b) a representation that is misleading in a material particular; or (c) conduct that is misleading or is likely or liable to mislead; and, in particular, does not imply that a representation that a person makes with respect to any future matter is not misleading merely because the person has reasonable grounds for making the representation. 149 For reasons already explained, s 4 is an evidentiary provision and does not shift the ultimate onus of proof. In the present case, the reasonable grounds relied upon by Reckitt are the existence of the Schachtel Study, the known results of the failed ASMI complaints brought by Glaxo against Reckitt and the circumstance that no clinical or scientific study undertaken subsequently to the Schachtel Study has demonstrated that its conclusions are incorrect or insupportable. 150 Glaxo submitted that Reckitt is obliged to prove that, in respect of the reasonable grounds ultimately relied upon by it at the hearing, it actually relied upon those grounds at the time when it made the representations (see Sykes v Reserve Bank of Australia (1998) 88 FCR 511 at 513-514 per Heerey J). Whether or not that is a true statement of the relevant law, I am prepared to infer from the existence of the matters relied upon by Reckitt as at August 2015 and from the fact that Reckitt has been shown to have known about Study NL9701 and the NCT Study as well as obviously knowing about the ASMI complaints and the outcome of those complaints, that Reckitt actually did rely upon those matters now invoked as reasonable grounds when it ran the campaign. For those reasons, I find that Reckitt has satisfied the requirements of s 4(2) of the ACL with the consequence that Glaxo must now establish, on the balance of probabilities, without the assistance of the presumptions embodied in s 4 of the ACL, that there was no adequate foundation in the body of scientific knowledge current in the period from August to December 2015 to support the making of the representations which I have found were made. 151 Glaxo sought to make good its case on this point by tendering the relevant studies and related documents and by relying upon the evidence of Professor Andrew Alexander Somogyi who, at the time of the hearing before me, was Professor in Clinical and Experimental Pharmacology at the University of Adelaide. Professor Somogyi is a distinguished academic with relevant expertise. 152 Reckitt also relied upon expert evidence. In its case, it called Professor Robert H Dworkin who, at the time of the hearing before me, was a Professor of Anesthesiology, Neurology and Psychiatry in the Center for Human Experimental Therapeutics and Director of the Anesthesiology Clinical Research Center at the University of Rochester School of Medicine and Dentistry. Professor Dworkin is also a distinguished academic with relevant expertise. 153 The two experts provided considerable assistance to the Court in understanding the relevant scientific material. They could not, of course, decide the ultimate question (whether Reckitt engaged in misleading or deceptive conduct or conduct that was likely to mislead or deceive or made false misrepresentations as alleged by Glaxo) but could, nonetheless, cast considerable light on the critical question in the case viz whether there was, in fact, at the relevant time, an adequate foundation in the body of scientific knowledge then known to support the representations which I have found were made.

The Joint Report of the Parties' Experts 154 The parties' experts were directed to confer and to provide to the Court a joint report in which they set out all matters upon which they agreed and all matters in respect of which no agreement could be reached. In respect of the non-agreed matters, the experts were directed to state briefly the reasons for the opinions held by each of them. 155 The experts complied with that direction and prepared a Joint Report dated 21 October 2016. That Report became Exhibit A at the hearing of the separate questions. On p 1 of the Joint Report, the experts set out in six pithy paragraphs the matters upon which they were agreed. In the succeeding pages (pp 2 to 5), the experts recorded the important matters of disagreement and the reasons therefor, as directed by the Court.

The Agreed Matters 156 The matters which were the subject of agreement were expressed in the following terms: 1. That ibuprofen 400 mg "provides an important benefit in terms of being pain free at 2 hours for a small number of people with frequent episodic tension-type headache who have an acute headache with moderate or severe initial pain" compared with placebo, as concluded by the Cochrane 2015 systematic review and meta-analysis "Ibuprofen for acute treatment of episodic tension-type headache in adults (Review)". The outcome of pain free at 2 hours has been recommended by the International Headache Society (IHS) as the primary efficacy outcome measure in clinical trials of tension-type headache (TTH). 2. That paracetamol 1000 mg "provided a small benefit in terms of being pain free at two hours for people with frequent episodic TTH who have an acute headache of moderate or severe intensity" compared with placebo, as concluded by the Cochrane 2016 systematic review and meta-analysis "Paracetamol for acute treatment of episodic tension-type headache in adults (Review)". 3. That in general, Cochrane systematic reviews and meta-analyses are a gold standard for evaluating and comparing medication efficacy (and safety) because they attempt to include all studies whether published or unpublished in peer-reviewed journals. 4. That to the extent the advertisement refers to common headaches and given that the Schachtel study investigated TTH, which is a common headache (as is migraine), we focus on TTH in our comments. 5. That the major Schachtel study results, based on the analyses presented in the Cochrane 2016 review, provide convincing evidence for the superiority of ibuprofen 400 mg over paracetamol 1,000 mg in TTH, with differences that can be considered clinically meaningful. Professor Dworkin provides more information regarding these results in point 2 of "We disagree on the following matters". 6. That the use of p values and 95% confidence intervals (CIs) complement one another and each provides valuable information when considering the results of clinical trials.

The Remaining Matters of Disagreement 157 After the experts' discussion, Professor Somogyi maintained that the authors of the Schachtel Study had not made clear whether the ibuprofen and paracetamol formulations used in that study were, in fact, equivalent to commercial and marketed formulations. He also queried whether those relying upon that study could assume that commercial formulations had been used. As the case progressed at the trial, this point paled into insignificance and was ultimately abandoned. 158 The second point of disagreement concerned whether or not it was legitimate for the Court to impute greater worth or value to the Schachtel Study because those who carried out the study (Professor Schachtel and others) were highly regarded and renowned researchers in the relevant area. Professor Dworkin argued that these factors were important in support of the validity of the Schachtel Study. Furthermore, he opined that, because Study NL9701 and the NCT Study did not produce results which were inconsistent with the Schachtel Study, the ultimate conclusions reached by the authors of the Schachtel Study remained as strong as they had been prior to the conduct of these later studies. Against this, Professor Somogyi opined that there were some difficulties with the Schachtel Study (although he accepted that it was a valid study) and that the meta-analyses relied upon by Glaxo did not support the ultimate conclusions reached by the authors of the Schachtel Study. These comments from the experts were relevant to enabling the Court to understand par 5 of the points of agreement in the Joint Report. 159 The third matter of disagreement involved the relevance of yet another study, the Packman study. Professor Somogyi took the view that the Packman Study was irrelevant because the administration of ibuprofen in that study was in a solubilised form in a capsule (liquigel) which would have enhanced the rate of absorption of that drug into the body. Professor Dworkin, on the other hand, considered the study to be relevant. He opined that the results of the Packman Study effectively replicated the Schachtel Study. 160 I think that the views of Professor Somogyi should be preferred on this point given the obvious and significant difference in the form in which ibuprofen was administered between the Packman Study and the Schachtel Study. 161 The next point of difference concerned whether or not it was appropriate to consider results from other musculoskeletal conditions such as lower back pain or osteoarthritis and migraine headache when evaluating the evidence suggesting that ibuprofen is superior to paracetamol for TTH. Professor Dworkin asserted that these other results were broadly relevant. Professor Somogyi considered them not to be so relevant. 162 Again, given the particular focus in the advertising and promotional materials upon common headaches including TTH, I prefer the views of Professor Somogyi. 163 The next point of difference was whether the IHS criterion of pain free at two hours should be the basis for efficacy comparisons. 164 Professor Somogyi asserted that the IHS standard should be that which is applied. Professor Dworkin disagreed, particularly when regard is had to the fact that it has no statutory or regulatory force and to the circumstance that there is little support in the science as to whether patients themselves consider this to be a more meaningful point in time to test than other possible points in time. Professor Dworkin did accept that pain free at two hours is a worthwhile primary end point for TTH clinical trials. 165 The final point of difference concerned the question of whether or not a finding of no statistically significant difference between ibuprofen and paracetamol for pain free at two hours in the Cochrane 2016 meta-analysis is inconsistent with the assertion of statistically significant superiority of ibuprofen over paracetamol as concluded by the authors of the Schachtel Study. 166 Professor Dworkin took the view that there was sufficient numerical superiority in the results to justify an assertion that ibuprofen was a superior product. Professor Somogyi, on the other hand, said that the differences were not statistically significant. The latter proposition was the correct proposition. 167 Notwithstanding that there was no statistical significance in the differences as demonstrated by the 2016 meta-analysis undertaken by Cochrane, this did not mean that the results of the Schachtel Study were invalid or incorrect. It simply meant, as the authors of Cochrane 2016 concluded, that: No authoritative comparisons between active treatments is possible in the present state of knowledge. 168 Ultimately, Professor Somogyi opined that the meta-analyses conducted post Schachtel (Moore, Cochrane 2015 and Cochrane 2016) did not support the results and conclusions set out in the Schachtel Study. Professor Dworkin took the view that the later meta-analyses did not invalidate the Schachtel Study. In scientific and statistical terms, both Professors were correct.

The Various Scientific Studies 169 In the present case, there are different types of studies comprising the relevant science. There are clinical trials (the Schachtel Study, Study NL9701 and the NCT Study) and systematic reviews and meta-analyses. As submitted by Glaxo, a systematic review is a literature review focussed on a research question to identify, appraise, select and synthesise all high-quality research evidence relevant to the question. Professor Somogyi said that, in the present case, what would be collected in such a review are all randomised, double blind trials of oral analgesics for the treatment of episodic TTH. 170 A meta-analysis is also a review but is one which is based upon the application of scientific and arithmetical computer programs. Both Professors agreed that the Cochrane meta-analyses are a gold standard for evaluating and comparing medication efficacy (and safety). In his first affidavit, Professor Somogyi said this about meta-analysis: … meta-analysis is specifically designed to pool data from across all available studies to report on the specified outcome as a culmination of all available studies. The process minimises any weight placed upon one particular study and gives appropriate weighting to all appropriate available data. 171 Both experts emphasised that a properly conducted meta-analysis pools the data (not the results) from the studies which are utilised for the purpose of the analysis. 172 Professor Dworkin agreed that well-conducted systematic reviews and meta-analyses are generally more informative than single clinical trials as they synthesise the results from all relevant studies.

The Schachtel Study 173 I have already made a number of observations about the Schachtel Study. 174 Glaxo accepted that the Schachtel Study was a properly designed and properly conducted clinical trial. 175 The Schachtel Study was incorporated in the Cochrane 2016 meta-analysis and picked up in the Moore Study. 176 Glaxo pointed to several matters which it described as "shortcomings" in the Schachtel Study. These were: (a) Participants in the study were probably not on site at the onset of the headache but rather had to travel to a clinic. Whether or not this was so is unclear; (b) The age of the participants in the Schachtel Study was in the range 22.3 years plus or minus 7.1 years. This is not truly representative of the entire population; and (c) If the study was conducted in a room at the clinic, it did not replicate the real world. 177 These "criticisms" of the Schachtel Study do not rise to a level where the reliability of the results of the study is in question. 178 The graph used in the advertisements is plainly based upon Figure 2 in the Schachtel Study. That figure is in the following form: 179 In the advertising and promotional materials published to the public at large, there is no explanation of the X and Y axes on the graph nor is there a reproduction of the placebo line on the graph. 180 The notes under Figure 2 in the Schachtel Study include the following statement: Ibuprofen is significantly different from acetaminophen at all time points after administration (P<0.01).

Study NL9701 181 This was a study commissioned by Boots (which was later subsumed into Reckitt) with patient enrolments in 1998. The clinical trial report was signed and approved in 2001. 182 The objectives of Study NL9701 (as stated therein) were: To evaluate the analgesic effectiveness at four hours after administration of ibuprofen (Nurofen) 400mg compared with commercially available paracetamol 1000mg and placebo for treatment of tension type headache. In addition, the study aimed to evaluate the analgesic effectiveness at two and six 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. 183 The two experts and the authors of the systematic reviews were all of the opinion that Study NL9701 was a well-designed, properly conducted and robust study. The quality of Study NL9701 was assessed as part of the Cochrane analyses under the Oxford Quality Rating Scale. It received a 4/5 rating in the Cochrane reviews. It did not receive a 5/5 rating because the randomisation method used was not reported in the available material and an assessment of that aspect of the study was not possible. However, the experts agreed that it makes no difference for present purposes that Study NL9701 achieved a 4/5 rating while the Schachtel Study received a 5/5 rating. 184 There were differences between the methodologies adopted in each of the Schachtel Study and Study NL9701. Principal among these differences were the circumstances in which the medication was administered including whether it was administered soon after the onset of the headache or after some lapse of time. 185 Study NL9701 showed that there was no statistically significant difference between ibuprofen and paracetamol pain free at two hours. The actual conclusion stated in Study NL9701 was: 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. 186 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. 187 Study NL9701 was not published. The decision not to publish was made by Reckitt or by Boots, its predecessor. The fact that the study was not published meant that it was not peer reviewed.

The NCT Study 188 The NCT Study also does not support the results of the Schachtel Study. However, as was the case with Study NL9701, it does not support the opposite proposition either.

The Moore Study 189 This is a paper by Professor Moore: 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). 190 The Moore Study was published in 2014. It was supported in part by Reckitt. 191 The Moore Study is a meta-analysis that was in existence and known to Reckitt when the campaign began in the present case. 192 The aims of the Moore Study were (as stated in the abstract): … to review methods, quality and outcomes reported (in particular the IHS-recommended primary efficacy parameter pain free after two hours), and to assess efficacy by meta-analysis. 193 The Moore Study included in its meta-analysis the Schachtel Study and Study NL9701. 194 For this reason, those studies passed the reliability threshold for inclusion in the meta-analysis with no emphasis being given to one or the other. 195 The authors of the Moore Study stated the results of their meta-analysis in Table 3. They concluded (at 2223): 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. 196 Professor Dworkin acknowledged that the results of the Moore Study meta-analysis did not support a difference in pain free at two hours between ibuprofen and paracetamol. 197 As submitted by Glaxo, Professor Dworkin: (a) Described Professor Moore as a leading expert in the field; (b) Accepted the Moore Study is a meta-analysis with its advantages over single clinical trials; (c) Acknowledged that the conclusion of the Moore study did not support the superiority of ibuprofen over paracetamol; (d) Never disagreed with that conclusion (whether in his affidavits, the joint report or in cross-examination); and (e) Insofar as he criticised the results of the Moore Study at all, did so in a subjective fashion which was not clinically meaningful or relevant. 198 As submitted by Glaxo, the Moore Study is, and was at August 2015, part of the current body of scientific knowledge. It did not support the advertising campaign.

The Cochrane Reviews 199 Cochrane 2015 was part of the body of scientific knowledge known as at August 2015. Cochrane 2016 was not. 200 The studies that were analysed in Cochrane 2016 were the Schachtel Study, Study NL9701 and the NCT. 201 Professor Dworkin accepted that Cochrane 2016 did not show a statistical superiority for ibuprofen for pain free at two hours. 202 As already mentioned, the authors of Cochrane 2016 concluded as follows: … 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). … No authoritative comparisons between active treatments is possible in the present state of knowledge. 203 Cochrane 2016 does not support the claims made by Reckitt in the campaign.

Cochrane 2015 204 In this study, the authors included the Schachtel Study and Study NL9701 but not the NCT Study. 205 The authors of Cochrane 2015 concluded that; … Ibuprofen 400mg is probably not much different from any other treatment, based on what is known. Again, no authoritative comparisons between active treatments is possible in the present state of knowledge.

Conclusions in Respect of the Scientific Knowledge 206 Glaxo submitted that, given the various studies forming part of the body of scientific knowledge relevant to the present case known at August 2015, simply citing, and reproducing, the results of the Schachtel Study in support of the representations which I have found Reckitt made in the campaign is misleading or deceptive and likely to mislead or deceive consumers. It also claimed that the representations were false within the meaning of s 29(1)(a) and s 29(1)(g) of the ACL. This is because, on balance, the studies to which I have referred do not speak with one voice on the question of whether ibuprofen (Nurofen) provides faster and more effective relief than paracetamol (Panadol). The Schachtel Study, taken alone, supports that proposition but Study NL9701 does not, nor does the NCT Study. Most importantly of all, however, none of the meta-analyses undertaken support the claim. 207 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. 208 Reckitt, of course, submitted that it was not misleading or false for it to conduct the campaign in the manner which it did in circumstances where it had clear support for its principal claims in the Schachtel Study and where no other study, either clinical trial or meta-analysis, suggested or established that the results of the Schachtel Study were invalid or unsupportable. In essence, Reckitt argued that the studies conducted subsequently to the Schachtel Study were entirely neutral on the question of whether the results of that study were valid or not thereby leaving the Schachtel Study having the full force and effect that its authors claimed. 209 For the reasons which I have explained, 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.

Conclusions 210 For the above reasons, I propose to grant appropriate relief by way of declaration and injunction. 211 As already noted (at [7] above), Glaxo abandoned any claim for an order for corrective advertising. The parties also requested that I give them time to consider these Reasons for Judgment before making orders. In those circumstances, I propose to allow the parties time to consider these Reasons for Judgment and to propound appropriate orders in light of these Reasons. 212 As Glaxo has been successful in this part of the case, I propose to order Reckitt to pay its costs of and incidental to the proceeding to date. That costs order should be incorporated in the parties' proposed Short Minute of Orders which I shall direct be provided to the Court. 213 There will be orders accordingly. I certify that the preceding two hundred and thirteen (213) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Foster.

Associate: Dated: 8 January 2018 ANNEXURE A ANNEXURE B ANNEXURE C ANNEXURE D ANNEXURE E

Trade Practices Act 1974(Cth)

THE COURT ORDERS THAT:

By 8 February 2018, the applicants file and serve a draft of the Orders which they consider appropriately reflect Reasons for Judgment published this day (8 January 2018) by Foster J (GlaxoSmithKline Australia Pty Ltd v Reckitt Benckiser (Australia) Pty Limited (No 2) [2018] FCA 1).
In the event that it disagrees with the applicants' proposed Orders, by 15 February 2018, the respondent file and serve a draft of the Orders which it considers appropriately reflect the said Reasons for Judgment.
Each party may support its draft with a written submission of no more than three (3) pages in length.
The form of relief to be granted in order to give effect to the said Reasons for Judgment be determined on the papers after 15 February 2018. Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

FOSTER J: 1 The applicants, GlaxoSmithKline Australia Pty Ltd and GlaxoSmithKline Consumer Healthcare Australia Pty Ltd (together, Glaxo), have for some considerable time marketed and sold, and continue to market and sell, a suite of over-the-counter (OTC) pain relief medications under the product name "Panadol". The active ingredient in all Panadol products is paracetamol (also known as acetaminophen). 2 Until 7 September 2015, the first applicant was the entity which marketed and sold Panadol-branded products in Australia. Since 7 September 2015, those activities have been conducted by the second applicant. 3 Both applicants claim the relief specified in their Fast Track Originating Application filed herein on 11 September 2015 (Application). 4 The respondent, Reckitt Benckiser (Australia) Pty Limited (Reckitt), also markets and sells a brand of OTC pain relief medication under the product name "Nurofen". Reckitt supplies a number of different products under the Nurofen product name. The active ingredient common to all Nurofen products is ibuprofen. 5 In August 2015, Reckitt commenced a comparative advertising campaign (campaign) in which it compared Nurofen and ibuprofen with Panadol and paracetamol. Glaxo alleges, amongst other things, that, in that campaign, Reckitt represented that: (a) Nurofen is better than paracetamol for common headaches. (b) Nurofen gives faster pain relief more effectively for common headaches than does paracetamol. (c) Nurofen is better than Panadol for common headaches. (d) Nurofen gives faster pain relief more effectively for common headaches than does Panadol. (e) Nurofen and ibuprofen perform in a superior manner to Panadol or paracetamol in delivering pain relief for headaches including tension-type headaches (TTH). 6 Glaxo contends that, at the time when Reckitt's campaign was conducted, there was no adequate foundation in scientific knowledge for the representations which Reckitt is alleged to have made during its campaign. As a consequence, Glaxo claims that Reckitt has engaged in misleading and deceptive conduct in contravention of s 18 of the Australian Consumer Law (ACL) and has made false representations in contravention of s 29(1)(a) and s 29(1)(g) of the ACL. 7 In its Application, Glaxo claims declaratory relief, a permanent injunction restraining the campaign and the making of claims similar to those made in the campaign, an order for corrective advertising, damages or compensation, interest and costs. It also claims unspecified orders under s 237 of the ACL. No particulars of any specific orders sought under that section were provided. During final address, Glaxo abandoned its claim for an order requiring corrective advertising. 8 This proceeding has quite a history in this Court. That history is recounted in an interlocutory judgment which I delivered on 7 October 2016 (GlaxoSmithKline Australia Pty Ltd v Reckitt Benckiser (Australia) Pty Ltd [2016] FCA 1196 (Glaxo No 1)). It is not necessary to repeat that history in these Reasons. 9 On 15 October 2015, I ordered, pursuant to r 30.01 of the Federal Court Rules 2011, that all questions of whether there has been any contravention of the ACL and the nature and form of any declaratory and injunctive relief to be granted to the applicants including relief by way of corrective advertising (the separate questions) be determined separately from and prior to all other issues. After the separate questions have been answered and any consequential orders made, the claims for relief which will remain are Glaxo's claims for pecuniary relief and s 237 orders. These claims will only need to be addressed if Glaxo is successful in the first part of the case. 10 The proceeding was removed from the Fast Track on 3 February 2016 as a result of delays caused by difficulties with an expert witness whom Reckitt had hoped to call at the hearing of the separate questions. 11 On 15 December 2015, Reckitt gave the following undertaking to the Court, namely: … that, on a without admissions basis, it will: (a) From 21 December 2015 to the commencement of the hearing, suspend the advertising campaign referred to in paragraphs 3 and 14 of the Amended Fast Track Statement, including, without limitation, all: (i) Television commercial advertising; (ii) Printed material including magazine and newspaper articles; (iii) Point of sale advertising at Woolworths, IGA and Metcash stores; (iv) Point of sale advertising at approximately 5,200 pharmacies; and (v) Outdoor advertising; (b) Use its best endeavours to withdraw: (i) Point of sale advertising at Coles stores scheduled to commence on 16 December 2015; (ii) Point of sale advertising at Chemist Warehouse stores scheduled to commence on 4 January 2016. 12 On 9 June 2016, the solicitors for Reckitt gave notice to the solicitors for Glaxo that Reckitt intended to resume the campaign immediately after the commencement of the hearing of the separate questions which, by then, had been fixed to commence on 25 October 2016. 13 This notification provoked the second applicant into filing an Interlocutory Application on 5 July 2016 (Glaxo's Interlocutory Application) by which the second applicant sought to restrain Reckitt from resuming the campaign until after the Court has determined the separate questions. In Glaxo No 1, I treated these claims for interlocutory injunctive relief as having been made by both applicants. 14 For the purposes of Glaxo's Interlocutory Application, Reckitt conceded that there was a serious question to be tried or prima facie case in respect of Glaxo's claims for final injunctive relief made in its Application. As a consequence of that concession, in Glaxo No 1, I did not need to consider whether Glaxo had established such a serious question or prima facie case nor did I need to assess the strength of that serious question or prima facie case (Warner-Lambert Co LLC v Apotex Pty Ltd (2014) 106 IPR 218 at 239 [97]). 15 By Glaxo No 1, I granted injunctive relief restraining the further conduct of the campaign by Reckitt until the final determination of the separate questions. That interlocutory relief remains in place.

The Relevant Legal Principles 46 At pars 18 to 29 of its Opening Outline of Submissions, Glaxo summarised the relevant legal principles governing the issues calling for determination in the present case. It did so by reference to the judgment of Wigney J in Australian Olympic Committee Inc v Telstra Corp Ltd [2016] FCA 857 at [132]. An appeal from his Honour's judgment was dismissed. In the course of their Reasons for Judgment (Australian Olympic Committee, Inc v Telstra Corporation Limited [2017] FCAFC 165 at [73]), the Full Court noted that neither party submitted on appeal that his Honour's summary of the relevant principles was defective in some way. The Full Court was content to proceed upon the basis that his Honour's summary was correct. 47 Paragraphs 18 to 29 of Glaxo's Opening Outline of Submissions were in the following terms: 18. Section 18 of the ACL is not limited to misleading and deceptive representations; cf s 29(1). The question is whether the respondent's conduct, which may include acts, omissions, statements or silence, is misleading or likely to mislead or deceive: Australian Competition and Consumer Commission v TPG Internet Pty Ltd (2013) 250 CLR 640 at 655 [49] (per French CJ, Crennan, Bell and Keane JJ). 19. Conduct is misleading or deceptive if it has a tendency to lead a person into error, or to believe what is in fact false. Conduct is likely to mislead or deceive if there is a real or not remote chance or possibility that it will have that effect: Global Sportsman Pty Ltd v Mirror Newspapers Pty Ltd (1984) 2 FCR 82 at 87-88. It is insufficient for the impugned conduct to only cause confusion or wonderment: Campomar Sociedad Limitada v Nike International Ltd (2000) 202 CLR 45 at 87 [106] citing the judgment of a majority of the Full Court in Taco Company of Australia Inc v Taco Bell Pty Ltd [1982] FCA 170; (1982) 42 ALR 177 at 201 (per Deane and Fitzgerald JJ). 20. The question whether conduct is misleading or deceptive is an objective question of fact that is to be determined on the basis of the conduct of the respondent as a whole viewed in the context of all relevant surrounding facts and circumstances. Viewing isolated parts of the conduct of a party "invites error": Butcher v Lachlan Elder Realty (2004) 218 CLR 592 at 625 [109] (per McHugh J); Campbell v Backoffice Investments Pty Ltd (2009) 238 CLR 304 at 341-342 [102] (per Gummow, Hayne, Heydon and Kiefel JJ). 21. The question involves the characterisation of the relevant conduct. Evidence that persons have in fact been misled or deceived by the conduct is not an essential element, however, it can in some cases be relevant and material: Parkdale Custom Built Furniture v Puxu Pty Ltd (1982) 149 CLR 191 at 198 (per Gibbs CJ). 22. The tendency of the conduct or representation to mislead or deceive is to be considered or tested against the ordinary or reasonable members of the class to whom the representation was made or the conduct directed. The question is whether a substantial, or at least a reasonably significant, number of that class is likely to be misled or deceived: see Optical 88 Ltd v Optical 88 Pty Ltd (No 2) [2010] FCA 1380 at [336]-[342]. The focus on ordinary or reasonable members of the relevant class of consumers means, in effect, that possible extreme, unreasonable or illogical reactions can be put to one side. 23. It is not necessary to prove that the respondent intended to mislead or deceive, however evidence of such an intention may constitute evidence that the conduct was likely to succeed in misleading or deceiving, and may make a finding of contravention more likely: Yorke v Lucas (1985) 158 CLR 661 at 666 (per Mason ACJ, Wilson, Deane and Dawson JJ). 24. Where the conduct or representation is in the form of an advertisement, the "dominant message" or "general thrust" of the advertisement is important. It is nevertheless important to have regard to the whole advertisement because context is or may be important. It may also be relevant to have regard to the external context in which a consumer is likely to view an advertisement: TPG Internet at 653-655 [45]-[49] (per French CJ, Crennan, Bell and Keane JJ). 25. Where the conduct or representation is in the form of words, it would be wrong to fix on some words and ignore others which may provide relevant context and give meaning to the impugned words. It is necessary to have regard to the whole document: Butcher at 638-639 [152] (per McHugh J). 26. While there are no special principles that apply to comparative advertising, factual assertions made by an advertiser must be true and accurate: Gillette Australia Pty Ltd v Energizer Australia Pty Ltd (2002) 193 ALR 629 at 633 [20] per Heerey J, at 640 [43] per Lindgren J and at 654 [91]-[93] per Merkel J. 27. A comparative, as distinct from a unilateral, promotion of a product necessarily indicates that the advertisement is not mere advertising puff, but involves representations of fact which are either true or false: Gillette (at 641 [44] per Lindgren J, referring to the authorities cited at 640 [43]). An advertiser can lawfully compare a particular aspect of its product favourably with the same aspect of a competitor's product provided the factual assertions are not untrue or misleading half-truths: Gillette (at 634 [22] per Heerey J). See also Stuart Alexander & Co (Interstate) Pty Ltd v Blenders Pty Ltd (1981) 53 FLR 307 at 310 per Lockhart J and Duracell Aust Pty Ltd v Union Carbide Aust Ltd (1988) ATPR ¶40-918 at 49,861 per Burchett J. 28. In assessing the impact of television commercials, the observations of Merkel J in Telstra Corporation Ltd v Optus Communications Ltd (1996) 36 IPR 515 are particularly apposite. Of the advertisements before him in that case, his Honour said: "They will be seen by the casual but not overly attentive viewer viewing a free-to-air program with only a marginal interest in the advertisements shown between the segments of the program. In that context it will be the first impressions conveyed to that viewer, rather than an analysis of the cleverly crafted constituent parts of the commercial, which will be determinative." Telstra (1996) 36 IPR 515 at 523-524; as applied in the context of corrective advertising in Medical Benefits Fund of Australia v Cassidy (2003) 135 FCR 1 at 23 [60] per Stone J (with whom, Moore J and Mansfield J relevantly agreed). 29. It is misleading conduct to make comparative efficiency claims that imply they were made on a scientific basis when, in fact, there is no proper scientific basis for making those claims: see Colgate Palmolive Pty Ltd v Rexona Pty Ltd (1981) 58 FLR 391; 37 ALR 391 per Lockhart J. Further, it can be misleading to make a statement which implies that there is an adequate scientific foundation in scientific knowledge to justify it [when] taken in its context the scientific statement quoted does not provide a proper foundation: Sterling Winthrop Pty Ltd v Boots Co (Aust) Pty Ltd (1995) 32 IPR 361 at 365 per Tamberlin J. 48 In its Opening Outline, Reckitt accepted much of what had been submitted on behalf of Glaxo in its Opening Outline. Reckitt submitted (correctly) that, when the Court comes to assess advertising of the kind under consideration in the present case, it is the dominant message which will be of crucial importance (Australian Competition and Consumer Commission v Coles Supermarkets Australia Pty Ltd (2014) 317 ALR 73 at 81 [41]). 49 Reckitt also submitted (correctly) that, where claims are made of a scientific nature, proof that there is no scientific foundation or no adequate scientific foundation for those claims may be sufficient to establish that the claims are misleading. 50 In Janssen Pharmaceutica Pty Ltd v Pfizer Pty Ltd (1985) 6 IPR 227, Burchett J said at 234: It was submitted by counsel for the respondent that the applicant had failed to prove positively that Vermox would not ever produce a migratory reaction in worms, and that a statement could not be said to be false or misleading within s 52 without such proof, there being no onus on the respondent to prove the truth of the statement. 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. I think the present is such a case. It is not without significance that the statement is made in a video distributed through pharmacies by a pharmaceutical company professing expertise in the area. The video represents its information as available to one who does research in appropriate libraries, and professes to be "presented as a service to the community by Pfizer" (these words are on the cover of the video, which also contains the sub-title "Worms - Knowledge and Treatment"). 51 In Sterling Winthrop Pty Ltd v Boots Co (Australia) Pty Ltd (1995) 32 IPR 361 at 365, Tamberlin J said: It can be misleading for a corporation which disseminates information not to put forward sufficient information to avoid the possibility that the recipient may be misled; cf Fraser v NRMA Holdings Ltd (1994) 124 ALR 548; ATPR 41-346 at 42,529-30. 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) 37 ALR 391; ATPR 40-242; 58 FLR 391; Duracell Australia Pty Ltd v Union Carbide Australia Ltd (1988) 14 ALR 293; ATPR 40-918; Janssen Pharmaceutical Pty Ltd v Pfizer Pty Ltd (1986) ATPR 40-654. 52 Justice Bennett expressed similar views in Johnson & Johnson Pacific Pty Ltd v Unilever Australia Ltd (No 2) (2006) 70 IPR 574 at 594 [105]: Unilever has represented to the consumer that the preference exhibited by Holiday Skin users is supported by the "use test". The study was silent as to the preference of Holiday Skin users under the age of 25, who represented a substantial proportion of those users. 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 (1985) 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. 53 Glaxo claims that, in all of the advertising and promotional materials, Reckitt makes statements of present and past fact as well as statements which are with respect to future matters. Glaxo relies upon a line of authority exemplified by the reasoning of Goldberg J in Australian Competition and Consumer Commission v Purple Harmony Plates Pty Ltd [2001] FCA 1062 at [18] where his Honour said: I am satisfied that the representations relied upon by the Commission have been made in the company's brochure and on the website. Almost all the representations were in terms which made them representations with respect to future matters. There were not merely representing matters of present or past fact; rather they were couched in terms that represented that the products presently possessed characteristics and benefits, the characteristics and benefits had been demonstrated to exist in the past and would be maintained and enjoyed in the future. Put shortly, the representations were saying that if a person was to buy the relevant product, it would display the relevant characteristic or produce the relevant benefit in the future after the purchase was made: see Australian Competition and Consumer Commission v Giraffe World Australia Pty Ltd (No 2) (1999) 95 FCR 302 at 332. 54 Similar reasoning was applied by Lindgren J in Australian Competition and Consumer Commission v Giraffe World Australia Pty Ltd (No 2) (1999) 95 FCR 302 at 331-332 [123]-[126] and by Dowsett J in Australian Competition and Consumer Commission v Danoz Direct Pty Ltd (2003) 60 IPR 296 at 324 [126]. 55 A representor who makes a representation with respect to a future matter which is challenged in Court must bring forward evidence that there were reasonable grounds for the making of that representation at the time that it was made if it wishes to avoid the presumptive consequences of engaging the operation of s 4 of the ACL. In the present case, Reckitt relies upon selected elements of the body of scientific knowledge current as at the time the relevant representations were made as constituting the necessary reasonable grounds. In effect, in the present case, the implied representation pleaded at par 15B of the AFTS captures the same idea or notion that underpins the legal requirement that there be reasonable grounds to support claims made with respect to future matters. The parties seem to accept in the present case that, once the Court has determined what representations were made by the impugned advertising and promotional materials, the question of whether or not those representations breached the ACL as alleged will be determined by the answer to a further question, namely, whether there was a current adequate foundation in scientific knowledge to support the claims being made. If there was such a foundation, Glaxo's case will fail. If there was not such a foundation, the conduct in question will be misleading or deceptive. Here, once there was some evidence tending to support a conclusion that such a foundation existed, the onus of proving that it did not support the claims made rests upon Glaxo.

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