Justice Foster of the Federal Court has held that Reckitt Benckiser (Reckitt) lacked an adequate foundation in scientific knowledge to make certain representations to Australian consumers, including that "Nurofen is better than Panadol and paracetamol for the treatment of common headaches" and, as a consequence, found that Reckitt's Nurofen advertisements comparing those products were misleading, deceptive and false under the Australian Consumer Law, and that a declaration and final injunction should be ordered. This case provides a useful guide regarding the level of scientific support required to make a legally acceptable representation regarding the performance of a product in comparison to a competitor's product.

Background

In 2015, we reported that the ACCC had successfully sued Reckitt for misleading and deceptive conduct regarding its Nurofen products targeting specific pain. This year, in an action commenced by GlaxoSmithKline Australia Pty Ltd and GlaxoSmithKline Consumer Healthcare Australia Pty Ltd (GSK), Reckitt has again fallen foul of the Australian Consumer Law regarding advertisements for its Nurofen products, this time with respect to an advertising campaign comparing the effect of Nurofen to the effect of Panadol for the relief of common headaches including tension-type headaches (TTH).

By a previous decision of Justice Foster, an interim injunction was ordered restraining Reckitt from engaging in further conduct of the advertising campaign until determination of whether there has been any contravention of the Australian Consumer Law and the nature and form of any declaratory and injunctive relief to be granted to the applicants. This interim injunction will remain in place until final orders are made. This decision considered and determined those matters.

The Representations

This case concerned an advertising and promotional campaign for Reckitt's Nurofen products, comprising print advertisements and a TV commercial. The advertisements presented a graph, which provides the results of a clinical trial (the Schachtel Study), which is said in the advertisements to demonstrate that Nurofen (with the active ingredient ibuprofen) provides faster and more effective pain relief than Panadol (with the active ingredient paracetamol). An example of the graph used in one of the advertisements is shown below.

(a) expressly represented that Nurofen, 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 TTH than does Panadol or paracetamol.

(b) expressly represented that 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) impliedly represented that, at the time when it conducted the campaign (August to December 2015), there was a current adequate foundation in scientific knowledge to support the representations set out in subparagraphs (a) and (b) above."

The outcome of the case therefore turned upon whether there was in fact an adequate foundation in scientific knowledge to support representations (a) and (b) above.

The Science

Reckitt and GSK referred to three clinical trials (the Schachtel Study, Study NL9701 and the NCT Study) and three meta-analyses (the Moore Study and two Cochrane reviews in 2015 and 2016 respectively) as the relevant scientific knowledge concerning comparisons between the effect of ibuprofen compared to the effect of paracetamol for the treatment of common headaches including TTH.

Both parties presented evidence from expert witnesses regarding interpretation of these studies and the conclusions to be drawn from them. Importantly, both experts agreed that Cochrane reviews were the "gold standard" for evaluating and comparing medication efficacy, because they attempt to include all studies whether published or unpublished in peer-reviewed journals.

Justice Foster found the following with respect to these studies:

  • The Schachtel Study supported the proposition that ibuprofen (Nurofen) provides faster and more effective relief than paracetamol (Panadol).
  • Both Study NL9701 and the NCT Study did not replicate the results of the Schachtel Study, nor did they invalidate or impugn the results of the Schachtel Study.
  • Both the Moore Study and the Cochrane reviews included in their review the Schachtel Study and Study NL9701, and Cochrane 2016 also included the NCT Study.
  • The Moore Study and the Cochrane reviews did not support the advertising campaign. These meta-analyses concluded that ibuprofen was not much different from any other treatment based on what was known.

The Outcome

Based on the findings outlined above, his Honour found that the balance of the scientific knowledge was that the Schachtel Study, taken alone, supports the proposition that "ibuprofen (Nurofen) provides faster and more effective relief than paracetamol (Panadol)", but Study NL9701 does not, nor does the NCT Study. Most importantly of all, however, none of the meta-analyses undertaken supported the claim.

On that basis, Justice Foster concluded that "it was too simplistic a view of the relevant body of scientific knowledge" for Reckitt to take support from the Schachtel Study on the basis that none of the other studies suggested or established that the results of the Schachtel Study were invalid or unsupportable.

His Honour concluded that "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". His Honour therefore found that Reckitt had contravened s 18 of the Australian Consumer Law. In addition, His Honour found that, by making the representations, Reckitt had also contravened ss29(1)(a) and (g) of the Australian Consumer Law by making false representations that the goods were of a particular standard and that the goods have certain performance characteristics.

Justice Foster stated that relief by way of declaration and injunction is appropriate, and has ordered the parties to file draft orders which they consider to reflect the reasons by 8 February 2018. The interim injunction will remain in place until the final orders have been made by his Honour.

Key Points for Comparative Advertising

  • A comparative 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. Comparative advertising is therefore lawful provided that the factual assertions are not untrue or misleading half-truths.
  • 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.
  • 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
  • In the pharmaceutical context, Cochrane reviews are the "gold standard" for evaluating and comparing medication efficacy.
  • Reliance on the results of a single clinical trial will amount to a misrepresentation if those results are not supported in other relevant studies. This is particularly the case if a less favourable conclusion is drawn in a meta-analysis such as a Cochrane review.