What you need to know
- In 2018, the Federal Court held that AFT contravened Australian consumer law by making representations in advertisements for its Maxigesic product that Maxigesic provided stronger and more effective relief from pain than over the counter doses of either paracetamol or ibuprofen alone.
- In the current matter, AFT was found to have contravened consumer law again and to have breached orders of the Court made in 2018 by making new representations that Maxigesic provided better and faster, or more efficacious, pain relief than either paracetamol or ibuprofen alone, which AFT thought were supported by new scientific evidence.
What you need to do
- Review advertisement material for products carefully and ensure that there is adequate scientific basis for making any specific representations.
- Exercise particular caution with advertising claims that draw comparisons with other products as these are likely to attract regulator and competitor scrutiny.
- Include footnotes in advertisements that provide consumers with information about the study or studies relied on.
Background
AFT Pharmaceuticals sought a declaration from the Federal Court that there was an adequate scientific foundation for statements made in an advertisement for its analgesic product "Maxigesic". Maxigesic is a combination ibuprofen/paracetamol medicine.
Reckitt Benckiser sells competing pain relief products in Australia. Reckitt disputed AFT's entitlement to the declaration on the basis that the claims made in the new advertisements did not have adequate scientific foundation, contravened the Australian Consumer Law (ACL) and conveyed representations that had been restrained in a 2018 proceeding.
As reported in our June 2020 edition of IP@Ashurst, in that proceeding, the Federal Court found that AFT contravened the ACL by publishing an earlier advertisement for Maxigesic, as representations in that advertisement lacked an adequate scientific foundation. The Court made orders restraining AFT from making representations that Maxigesic provides stronger and more effective relief from pain than over the counter doses of either paracetamol or ibuprofen alone without an adequate scientific foundation for doing so.
AFT then released new advertisement material (New Advertisements) which made claims to the effect that Maxigesic provides "better and faster" pain relief than paracetamol or ibuprofen alone. The advertisements contained footnotes directing readers to information about a 2018 study by Daniels et al. (Daniels) which AFT relied on as the scientific foundation of its claims. This study was not considered by the 2018 judgment.
Daniels 2018 study
AFT relied on Daniels as the basis of the representations made in the New Advertisements. Daniels compared a fixed dose combination of 975mg paracetamol/292.5mg ibuprofen (the Daniels FDC), paracetamol alone, ibuprofen alone and a placebo. The study concluded that the Daniels FDC provided superior analgesia to either ingredient alone in the treatment of moderate to severe pain in the 48 hours after dental extractions, and had a shorter onset of meaningful pain relief.
Expert evidence indicated that the primary end point of the study provided information about the extent of pain relief over 48 hours, but not about the time to pain relief. The study's findings were limited to adults and to a dental pain model and were not directly informative of the degree of pain relief or onset of pain relief in contexts other than acute pain dental impaction settings.
The secondary end point of the study related to the time to meaningful pain relief, though experts raised doubt about the reliability of Daniels' secondary end points as adequate scientific foundation for AFT's claims as the study did not make statistically significant conclusions on the time to pain relief.
AFT's claims were based on the proposition that the Daniels FDC and Maxigesic are bioequivalent, though Daniels FDC contained approximately 2.6% less of each active ingredient than Maxigesic. A footnote included in the New Advertisements relied on a study by Aitken et al (Aitken) to demonstrate bioequivalence. However, experts disagreed whether the two were bioequivalent. Accordingly, Justice Gleeson considered the Aitken study did not provide unqualified support that the two products are bioequivalent. However, Aitken did show that the two products were bioequivalent in clinically relevant conditions, and on that basis, Daniels could be extrapolated to Maxigesic, to an extent.
Did Daniels support the claims in the New Advertisements?
Better pain relief
Justice Gleeson considered that Daniels provided foundation for the claim that Maxigesic provided better pain relief than paracetamol or ibuprofen alone, but the study could not be extrapolated to an unqualified statement that Maxigesic is more efficacious than paracetamol or ibuprofen alone in all contexts.
Faster pain relief
Justice Gleeson considered that Daniels provided an adequate scientific foundation for the claim that Maxigesic provides "faster onset of meaningful pain relief than for paracetamol or ibuprofen alone" where the statement is limited to the speed of onset measured by Daniels (extrapolated onto Maxigesic on the basis of Aitken). However, Daniels does not support any broader claim, such as the statement that Maxigesic provided "faster pain relief", as the Daniels FDC results did not achieve statistical significance for all secondary end points relating to time to pain relief. Daniels also did not assess the comparative efficacy of either paracetamol or ibuprofen alone so could not support a claim that Maxigesic provides faster pain relief than either paracetamol or ibuprofen.
Did the claims have an adequate scientific basis?
Justice Gleeson held that AFT had adequate scientific foundation, based on Daniels read together with Aitken, for some statements in the New Advertisements to the extent they are read as reporting the results of Daniels (for example, in conjunction with a footnote to the study) including:
- “Faster onset of meaningful pain relief than for Paracetamol or Ibuprofen alone”;
- “PROVEN TO PROVIDE MORE EFFECTIVE PAIN RELIEF IN A NEW CLINICAL STUDY” ; and
- “36% MORE EFFECTIVE THAN IBUPROFEN & 78% MORE EFFECTIVE THAN PARACETAMOL”.
However, Daniels did not provide adequate scientific foundation for the unqualified claims which were, accordingly, misleading and deceptive including:
- Maxigesic is more efficacious than paracetamol or ibuprofen alone; and
- Maxigesic provides better and faster pain relief than both paracetamol or ibuprofen alone.
By making these representations, AFT contravened ss 18, 29(1)(g) and 33 of the ACL and breached the Federal Court orders made in 2018 (and which were upheld in the 2020 appeal decision).
Authors: Philippa Anstey, Lawyer; and Kellech Smith, Partner.
