In recent years, the Australian Competition and Consumer Commission (ACCC) has cracked down on misleading advertising claims made by drug companies. These efforts align with a community expectation that over-the-counter (OTC) medicines are accurately represented. As a result, the industry has seen big players pay substantial fines where claims of a scientific nature are made without a solid scientific foundation for those claims.

In recent proceedings in the Federal Court of Australia, however, it was Reckitt Benckiser who successfully brought action against its commercial rival AFT Pharmaceuticals (AFTP) for misleading and deceptive conduct in an advertising campaign comparing the two companies’ pain relief products.

What's happened?

The proceedings follow a regulatory change in February 2018 reclassifying codeine and codeine-based analgesics from an OTC medicine to a prescription-only medicine. The regulatory change prompted two pharmaceutical leaders, Reckitt and New Zealand drug company AFTP, to launch advertising campaigns marketing their pain relief products as alternatives to codeine.^[1] Reckitt markets and sells Nuromol (500mg of paracetamol and 200mg of ibuprofen in a single capsule at a maximum recommended daily dosage of three tablets) and AFTP markets and sells Maxigesic (500mg of paracetamol and 150mg of ibuprofen in a single tablet with a daily dosage of eight tablets). Each advertising campaign included a number of claims comparing these products against one another, including representations by AFTP that Maxigesic was more effective than Nuromol (Effectiveness Claim).

Reckitt brought proceedings against AFTP alleging the Effectiveness Claim was misleading and deceptive. AFTP subsequently cross-claimed on similar grounds against Reckitt. Effectively, both parties alleged that the other breached the Australian Consumer Law (ACL) in claiming their product was superior to the other without an adequate foundation in scientific knowledge.

Reckitt’s case against AFTP

Reckitt’s case concerned an AFTP print advertisement, a Maxigesic card and a Maxigesic pamphlet. All three publications were directed at pharmacists and other health professionals. The representations published in the various advertisements included, amongst other things, claims that:

1. Maxigesic provides stronger and more effective pain relief from all pain than Nuromol when taken at their respective maximum recommended daily doses.
2. When taken at their respective maximum recommended daily doses, Maxigesic provides stronger and more effective pain relief from pain than any other paracetamol / ibuprofen combination.
3. When taken at their respective maximum recommended daily doses, Maxigesic provides stronger and more effective pain relief from pain than OTC doses of either paracetamol or ibuprofen alone.
4. Maxigesic reduces pain by at least 32 percent more than a full daily OTC dose of either paracetamol or ibuprofen alone throughout the period of administration of either drug.

The advertisements included reference in footnotes to clinical studies and also used percentages and charts that had the overall effect of conveying to the reader that AFTP had a ‘current adequate foundation in scientific knowledge’ for the Effectiveness Claims.

AFTP’s cross-claim against Reckitt

AFTP’s cross-claim against Reckitt related to:

• four print advertisements directed at pharmacists and pharmacy assistants
• two television advertisements presenting case studies relating to the use of Nuromol.

The advertisements effectively represented that Nuromol provides up to eight hours of pain relief in a single tablet, while other paracetamol/ibuprofen combinations like Maxigesic may require up to two tablets and six hourly dosing for optimal relief. In making these claims, the Reckitt referenced at least two clinical studies in support of the comparison.

Court’s findings

Regarding Reckitt’s claim, the Federal Court concluded that by publishing the various advertisements, AFTP contravened the ACL in two respects:

• By misleadingly representing that 'Maxigesic goods were of a particular quality, namely, able to provide the stronger and more effective pain relief referred to in the representations', when the evidence did not establish this was the case.
• In making the Effectiveness Claims in the context of charts, percentages, and footnotes, AFTP impliedly represented the Effectiveness Claims were “statements in the realm of science", which was not the case, as the scientific data was inconclusive and did not provide a proper foundation for the claims.

The Court reached a similar conclusion regarding Reckitt’s Nuromol advertising, finding that when the studies were interpreted with the assistance of expert evidence, there was no adequate scientific foundation for the representation that Nuromol provided superior pain relief to Maxigesic. Accordingly, the representation was also found to be misleading in breach of the ACL.

Key takeaways

This case highlights some important lessons for all industries seeking to make representations based in scientific fact and/or engage in comparative advertising. Some steps businesses can take to avoid similar consequences to those faced by AFTP and Reckitt in this case are:

1. approach comparative advertising with caution and ensure that all claims are supported by conclusive factual or scientific knowledge
2. when relying on data taken from scientific research, be wary that how the information is expressed (for example, by using percentages and charts) can also create a misleading impression and care should be taken not to overstate the strength of the scientific evidence due to the manner of presentation.