AstraZeneca Runs Out Of Puff

The "Seretide" war reached the Full Court of the Federal Court in Australia this month. The central issue in the case involved the question of whether two flyers sent to some 14,000 general practitioners in Australia and two advertisements published in "Australian Doctor" magazine relating to Glaxo's "Seretide" combination inhaler were misleading and deceptive or likely to mislead or deceive in contravention of the Australian Trade Practices Act.

The flyers and the advertisements all sought to promote the prescription by doctors of Glaxo's combination inhaler for the control of asthma either under the name "Seretide" or "Seretide Total Control". Each of the flyers and advertisements referred to an article published in the American Journal of Respiratory and Critical Care Medicine. That article reported on the findings of a study known as the "Goal" study. The study related to the control of asthma with a combination Salmeterol/Fluticasone treatment.

AstraZeneca complained that Glaxo had made a number of misrepresentations in the flyers and the advertisements namely:

1. that all or virtually all asthma patients will achieve 100% control or total control of all asthma symptoms by using Seretide;
2. that a majority (ie greater than 50%) of all asthma patients will achieve 100% control or total control of all asthma symptoms by using Seretide;
3. that a sufficiently high proportion of all asthma patients will achieve 100% control or total control of all asthma symptoms by using Seretide to justify the use of the brand slogan "Seretide total control";
4. that 41% of all patients taking part in the study known as the "Gaining Optimal Asthma Control" study published in the American Journal of Respiratory and Critical Care Medicine in 2004 (Goal study) achieved 100% control of all asthma symptoms by using Seretide;
5. that 41% of all patients taking part in the Goal study achieved "total control" (as that term is defined in the Seretide advertisements) of all asthma symptoms by using Seretide;
6. that 71% of all patients taking part in the Goal study achieved "well controlled asthma" (as that term is defined in the Seretide advertisements) of all asthma symptoms by using Seretide; and
7. that the patient results of the Goal study identified in paragraphs (d) (e) and (f) will be likely to be achieved in clinical practice.

At first instance the judge had dismissed all of AstraZeneca's complaints. The Full Court noted that:

1. Each of the flyers and advertisements complained about referred to the article report of the Goal study published in the American Journal of Respiratory and Critical Care Medicine and bore an endorsement in or to the following effect:

"PLEASE REVIEW PRODUCT INFORMATION BEFORE PRESCRIBING".

2. In each instance where the expression "Seretide Total Control" had been used in the flyers and advertisements, an asterisk had been added directing the reader's attention to a footnote summarising the Goal study.
3. The footnotes appeared in an easy to read type size on each of the original documents.

The Full Court held that, in determining whether there had been a contravention of the Trade Practices Act, it was necessary for the court to determine whether or not the conduct complained of amounted to a representation which has or would be likely to lead to a misconception arising in the minds of that section of the public to whom the conduct has been directed.

The Full Court followed previous authority to the effect that an asterisk can be sufficient to draw the attention of a consumer to a qualification of a representation however the qualifying material must be sufficiently prominent to prevent the primary statement from being misleading and deceptive or likely to mislead and deceive.

Viewing each of the flyers and advertisements as marketing documents directed by Glaxo to ordinary or reasonable members of the community of general practitioners throughout Australia the Full Court was unable to find that any of them made the representations alleged by AstraZeneca.

It was held that the term "Seretide Total Control" was, in effect, an alternative brand name adopted by Glaxo for its Seretide medication. In any event, the footnotes were sufficient to overcome any misrepresentation that might otherwise have arisen.

The difficulty for AstraZeneca was that it was forced to concede that the qualified statements made about Seretide were, in fact, true.

This left the Full Court with the alleged representation that each of the flyers and advertisements represented to ordinary or reasonable members of the community of general practitioners throughout Australia that;

AstraZeneca's position in relation to this alleged representation was that, while it conceded the truth of the matters represented by the flyers and the advertisements to which the 41% and 71% figures related it did so only in "an absolute statistical sense". It argued that the references to the Goal study in the flyers and the advertisements were deficient in that they failed to point out that the Goal study did not include patients with significant related diseases, smokers and patients under the age of 12 years. Although the Full Court accepted that the flyers and advertisements did not include any such qualification, it also found that there was no representation that the Goal study patients were representative of the asthma suffering members of the community at large.

Consequently, AstraZeneca failed to establish any of the alleged misrepresentations it asserted Glaxo had made.

This case, once again, emphasises that advertisements and promotional material need to be considered in context and from the viewpoint of the likely effect of the advertisement or promotion on ordinary and reasonable members of the section of the community towards whom the conduct has been directed. In the case of advertising and promotion to medical practitioners who are a sophisticated and highly qualified section of the community, it may take more to establish a misrepresentation.

Where complaint is made of implied misrepresentations said to arise in the course of advertising or promotion of a product, considerable care needs to be exercised before commencing litigation. One can only observe that the total vindication of Glaxo's position in this case only allowed it to strengthen its marketing position in relation to Seretide.

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