What you need to know
- In January 2018, the Federal Court of Australia held that Reckitt Benckiser’s (Reckitt) advertising campaign comparing Reckitt’s ibuprofen product Nurofen® against paracetamol for “common headaches” was misleading, deceptive and false in breach of sections 18, 29(1)(a) and 29(1)(g) of the Australian Consumer Law (ACL).
- Reckitt admitted that the advertising campaign (consisting of print advertisements and TV commercials) conveyed the representations that Nurofen® was “better than” or “superior to” paracetamol (including Glaxo SmithKline’s (GSK) Panadol® products) for common headaches, including tension-type headaches (TTH), and provided faster and more effective pain relief than Panadol® for common headaches (the Comparative Nurofen® Campaign). Reckitt also admitted that its advertisements conveyed to consumers that these representations were based on adequate scientific knowledge.
- In finding that Reckitt’s conduct breached the ACL, Justice Foster considered that the single scientific study relied on as the foundation for the representations in the campaign was not supported by subsequent studies and meta-analyses. It was thus misleading or deceptive, and false, for Reckitt to represent the superiority of ibuprofen over paracetamol for common headaches.
- His Honour granted a permanent injunction preventing Reckitt from making the same, or similar claims, and ordered that Reckitt pay GSK’s costs.
What you need to do
- Be cautious when making comparative product claims as comparative advertising is likely to attract close attention from competitors and regulators. When in doubt, obtain legal advice before commencing the advertising campaign.
- When engaging in comparative advertising, it is essential that any factual assertions are accurate and that the comparison is made between the same or equivalent features of a competitor’s product.
- If your comparative advertising campaign makes claims of a scientific nature, the representations may breach the ACL absent a proper scientific basis for making the claim, or where the scientific foundations are inadequate.
- Ensure that any scientific studies relied upon to support the claims are supported by other similar studies on the same subject matter, and not contradicted or undermined by subsequent research in the same field. This is particularly acute in the pharmaceutical industry. Before relying on a single clinical trial to support a claim of improved efficacy between medicines, it is important to ensure that the trial conclusions are consistent with other studies, or meta-analysis such as Cochrane reviews.
Background
The dispute with GlaxoSmithKline Australia Pty Ltd and GlaxoSmithKline Consumer Healthcare Australia Pty Ltd (GSK) in relation to the Comparative Nurofen® Campaign, is the second time in recent years that Reckitt has been placed under scrutiny for its Nurofen® advertisements. As we reported last year in our April 2017 Consumer Law and Pharmaceutical Update, Reckitt was ordered to pay $6 million in penalties following a finding that its sale and marketing of a range of pain-specific Nurofen® products contravened section 33 of the ACL.
The Comparative Nurofen® Campaign was first launched by Reckitt in around August 2015. GSK successfully sought an interim injunction to restrain Reckitt from conducting the Comparative Nurofen® Campaign (or any similar advertisements) until Reckitt’s liability for the alleged breaches of the ACL had been finally determined (GlaxoSmithKline Australia Pty Ltd v Reckitt Benckiser (Australia) Pty Ltd [2016] FCA 1196).
Reckitt's advertising campaign
The Comparative Nurofen® Campaign consisted of print advertisements in major magazines and trade publications (such as Retail Pharmacy and the Australian Journal of Pharmacy), in-store advertisements, outdoor advertising, promotional banners and television commercials.
Each of the advertisements contained statements to the effect that Nurofen® was “superior to paracetamol”, “better than paracetamol”, “more effective” for TTHs or common headaches and/or provided “faster pain relief”. These statements were displayed alongside a graph which depicted a relative relationship between the impact of Nurofen® and paracetamol on pain (based on patient relief ratings) over time (in hours). Although there were minor differences between each advertising format, this graph was substantially reproduced from a clinical trial (the Schachtel Study) which was referenced as a footnote below the graphs in the advertisements.
The representations: admitted and disputed
Reckitt admitted that the Comparative Nurofen® Campaign conveyed the following representations:
- Nurofen® is better than Panadol® (or paracetamol) for common headaches;
- Nurofen® is superior to Panadol® (or paracetamol) for common headaches;
- Nurofen® is superior to paracetamol for TTH;
- Nurofen® gives faster pain relief and is more effective than Panadol® (or paracetamol) for common headaches.
GSK alleged that the Comparative Nurofen® Campaign conveyed the following additional representations, which were denied by Reckitt:
- Nurofen® is better than Panadol® (or paracetamol);
- Nurofen® is superior to Panadol® (or paracetamol); and
- Nurofen® gives faster pain relief and is more effective than Panadol® (or paracetamol).
Reckitt contended that all representations were confined to specific pain conditions (ie relieving pain from common headaches, including TTH), and were adequately founded on scientific knowledge current at the time each representation was made.
Justice Foster found that the Comparative Nurofen® Campaign:
- expressly represented that Nurofen® (and thus ibuprofen) when taken in the recommended dose, as directed by the manufacturer, generally delivers faster and more effective relief from pain caused by common headaches (including TTH) than does Panadol® (or paracetamol);
- expressly represented that Nurofen® was better than Panadol® for the treatment of common headaches (including TTH) and performs in a superior manner in
delivery of pain relief for these types of headaches; and
- impliedly represented that, at the time when the campaign was conducted, there was an adequate scientific knowledge to support the express representations
Scientific basis of representations was inadequate
Justice Foster’s findings on the adequacy of the scientific basis for Reckitt’s representations were central to the determination of Reckitt’s liability under the ACL.
Relevant scientific literature
In assessing whether the body of science relied on by Reckitt at the time the representations were made provided a reasonable basis for the claims, his Honour considered evidence of three clinical trials (the Schachtel Study, Study NL9701 and the NCT Study), three “meta-analyses” (two Cochrane reviews from 2015 and 2016, and the Moore Study), and testimony from the parties’ expert witnesses opining on the relevance of the studies.
A meta-analysis is a systematic review of literature which applies scientific and arithmetical computer programs to identify, appraise, and synthesise all high quality research evidence on particular research questions. The parties’ experts agreed that the Cochrane meta-analyses were the “gold standard” for evaluating and comparing medication efficacy.
The relevant publications comparing paracetamol and ibuprofen in terms of speed and efficacy of treatment were as follows:
- Schachtel Study: the Schachtel Study was a single clinical trial conducted in 1996, and reported statistically significant superiority of ibuprofen (400mg) over paracetamol (1000mg) in the treatment of muscle contraction headaches.
- Study NL9701 and the NCT Study: Study NL9701 was commissioned by pharmacy chain Boots in 1998. The study compared the effectiveness of 400mg ibuprofen with 1000mg paracetamol and placebo four hours post-administration, for treatment of TTH. The authors concluded that there was no statistically significant difference between ibuprofen and paracetamol after 2 hours. While not supporting the conclusion reached in the Schachtel Study, neither Study NL9701 nor the NCT Study supported the opposite proposition either.
- Moore Study: the Moore Study was a 2014 meta-analysis which reviewed the outcomes reported in studies considering the efficacy of treatments for TTH. The Schachtel Study and Study NL9701 were included in the analysis. Reckitt’s expert witness acknowledged that the Moore Study did not support a difference in being pain free at two hours between ibuprofen and paracetamol.
- Cochrane Reviews: the 2015 Cochrane Review concluded that 400mg ibuprofen was “probably not much different from any other treatment” and that “no authoritative comparisons between active treatments is possible in the present state of knowledge”. The 2016 Cochrane Review (although not available at the time Reckitt launched the Comparative Nurofen® Campaign), found that there was “very low quality evidence” suggesting a statistical difference between being pain free at four hours for paracetamol and ibuprofen, and no difference at two hours.
To defend GSK’s allegations, Reckitt relied principally on the results of the Schachtel Study, and the fact that no other clinical trial had proven the opposite of those results or put those results into doubt.
Findings
Justice Foster considered that the balance of the scientific evidence did not “speak with one voice” on the issue of whether ibuprofen (Nurofen®) provides faster and more effective relief than paracetamol (Panadol®). Significantly, the findings of the Schachtel Study were not corroborated by the meta-analyses undertaken on the issue.
For these reasons, the Court held that it was misleading or deceptive, or likely to mislead or deceive consumers, for Reckitt to simply cite and reproduce the results of the Schachtel Study as a foundation for the claim that ibuprofen (Nurofen®) provides faster and more effective relief from pain caused by common headaches including TTH than does paracetamol (Panadol®). These representations were also held to be false within sections 29(1)(a) and 29(1)(g) of the ACL as the balance of scientific knowledge weighed against the Schachtel Study.
Relief
His Honour proposed to grant a permanent injunction and declaratory relief against Reckitt, as well as ordering Reckitt to pay GSK’s costs. GSK had previously sought, but subsequently abandoned, a claim for an order for corrective advertising.
Reckitt has appealed the decision to the Full Federal Court.
Authors: Kellech Smith, Partner; and Colette Downie, Lawyer.
