What you need to know
- AFT made unqualified representations about the clinical efficacy of its Maxigesic product when compared with Reckitt's Nuromol product.
- Although there were some scientific studies that arguably supported AFT's position, others cast doubt on AFT's representations.
- Taking into account the totality of the scientific evidence, the Full Court upheld the primary judge's conclusion that AFT's representations were misleading and deceptive.
What you need to do
- Be careful not to "cherry pick" the results of scientific studies in order to substantiate representations that you are making, particularly when there is competing scientific evidence casting doubt on those representations.
- Ensure that the balance of the available scientific evidence supports any representations that you make, or that any representations are suitably qualified.
Background
This case was an appeal from Reckitt Benckiser (Australia) Pty Limited v AFT Pharmaceuticals (AU) Pty Limited [2018] FCA 1552. AFT Pharmaceuticals (AU) Pty Ltd (AFT) and Reckitt Benckiser (Australia) Pty Ltd (Reckitt) are competitors in the sale of pain relief medication.
AFT offers for sale a product called "Maxigesic" (in tablet form) and Reckitt offers for sale a product called "Nuromol" (in capsule form). Both contain a combination of paracetamol and ibuprofen as the active pharmaceutical ingredients.
AFT's marketing campaign
In 2017, AFT engaged in a comparative advertising campaign. AFT made representations that, when taken at their maximum recommended daily doses:
- Maxigesic provides stronger and more effective pain relief than Nuromol; and
- Maxigesic provides stronger and more effective pain relief than any other over the counter (OTC) paracetamol and ibuprofen combination (the Representations).
When taken at their maximum recommended daily doses, Maxigesic provides 2500mg more paracetamol and 600mg more ibuprofen than Nuromol.
The advertisements were targeted at health professionals (pharmacists and support staff providing pain relief advice in relation to OTC pain relief products).
The Full Court considered that the Representations "carried an unqualified representation that they were a statement of scientific fact and that there is an adequate scientific foundation for them." Therefore, the issue for the Court to determine was whether the Representations had an adequate scientific foundation.
The scientific evidence
The primary judge found that the Representations did not have an adequate scientific foundation and were therefore misleading or deceptive or likely to mislead or deceive contrary to s 18 and other provisions of the Australian Consumer Law.
AFT submitted that the primary judge made errors when considering the scientific evidence.
Absence of a "head to head" study
One of the factors taken into account by the primary judge was that there was no "head to head" scientific study which directly determined the efficacy of the two products in question at each of their maximum recommended daily doses.
AFT argued that the primary judge had erred by taking this factor into account, and that a head to head study was not required for AFT to substantiate the Representations. The Full Court disagreed. The absence of a direct scientific comparison was a relevant factor, because it made it necessary for the primary judge to extrapolate the findings from various scientific studies in order to determine if the Representations could be substantiated.
The Full Court considered that the primary judge did not require a head to head comparison in order to justify the Representations. Rather, the absence of such a comparison was one of a number of factors taken into consideration when the primary judge considered the totality of the evidence.
Competing scientific evidence
Despite there being some studies that compared the efficacy of combination paracetamol/ibuprofen products, those studies were all based on single doses, not the maximum daily doses referred to in the Representations. Many of the studies did not find statistically significant differences between different doses of paracetamol and ibuprofen in combination, or were inconclusive.
The Full Court acknowledged that findings could be "cherry picked" from some of the studies to provide some support for AFT's position. The Full Court stated that "the existence of some favourable studies is, however, insufficient to show that the primary judge erred in assessing the evidence and reaching the conclusion that she did."
The Full Court held that "having regard to the totality of the scientific evidence before the Court, her Honour’s assessment of the appropriate balance of the evidence was plainly open". The Full Court therefore upheld the primary judge's decision that the Representations were misleading or deceptive.
AFT also argued that the primary judge had, in effect, reversed the onus of proof because any doubt about the scientific foundation for the Representations was resolved in favour of Reckitt (who commenced the action), rather than AFT. The Full Court disagreed, and considered that this argument did not give due consideration to the primary judge's reasoning.
Authors: Zack Di Pasquale, Lawyer; and Stuart D'Aloisio, Partner.
