INSIGHT

No relief from pain for Maxigesic claims

By Nick Li
Consumer law Intellectual Property Patents & Trade Marks

In brief 3 min read

AFT Pharmaceuticals (AU) Pty Limited v Reckitt Benckiser (Australia) Pty Limited [2020] FCAFC 45 serves as an important reminder of the risks of comparative advertising and the need for adequate scientific foundations to support representations claiming to be based in science.

Key takeaways

  • Representations of scientific fact must be supported by adequate scientific foundations.
  • Simplistic and unqualified representations are more likely to be misleading.
  • Comparative claims are particularly high risk. Review the supporting evidence carefully and avoid relying on extrapolation of the existing literature.

Who in your organisation needs to know about this?

Legal and marketing.

Full Court confirms Maxigesic promotional materials misleading

The Full Court, in dismissing AFT Pharmaceuticals (AU) Pty Limited's (AFT) appeal, held that claims made by AFT in promotional materials relating to its over-the-counter paracetamol and ibuprofen combination product, Maxigesic, were simplistic and unqualified statements not adequately supported by science.

Background

This case is an appeal from the primary judgment in Reckitt Benckiser (Australia) Pty Limited v AFT Pharmaceuticals (AU) Pty Limited [2018] FCA 1552. In 2017, in anticipation of the regulatory ban on over-the-counter codeine-based analgesics, AFT and Reckitt each promoted their non-codeine paracetamol/ibuprofen combination analgesic products, Maxigesic and Nuromol, respectively.

An example of the Maxigesic promotional material is set out below.

Example of the Maxigesic promotional material

The two products contained the same amount of paracetamol in each tablet, while Maxigesic had 50mg less ibuprofen than Nuromol per tablet. However, Maxigesic had a higher approved maximum daily recommended dose than Nuromol (8 tablets to 3 tablets), totalling 2500mg more paracetamol and 600mg more ibuprofen than Nuromol.

Representations

On appeal, AFT did not challenge the primary judge's findings that its promotional materials (including as depicted above) represented that:

  • Maxigesic provides stronger and more effective relief from all pain than:
    • Nuromol;
    • any other paracetamol/ibuprofen combination; and
    • paracetamol or ibuprofen alone,

when taken at their respective maximum recommended daily doses; and

  • Maxigesic reduces pain by at least 32% more than a full daily over-the-counter dose of either paracetamol or ibuprofen alone throughout the period of administration of either drug.

Further, AFT accepted on appeal that there was an implied representation that each representation was grounded in adequate scientific foundation, and that the latter two representations were supported by a scientific study – the Merry Study.

AFT did not appeal the primary judge's conclusions in relation to the scientific literature. It argued that the primary judge misapplied the legal test and effectively reversed the onus. It argued that the onus was on Reckitt to establish that the scientific foundation did not exist; that at best it had only proven the possibility that the higher doses did not result in stronger pain relief, and that this was not enough for it to succeed.

The Full Court rejected AFT's submissions. AFT had represented that the unqualified comparative claims were statements of scientific fact. For the claims not to be misleading, they needed to be adequately supported by science. In those circumstances, for Reckitt to succeed, it was sufficient for it to show, on the balance of probabilities, that either the science was inconclusive or that the position in science definitively contradicted AFT's claims. The primary judge concluded on the evidence that the former had been established and, therefore, did not err in finding against AFT.