A recent Decision from NAD serves as an excellent reminder that, in advertising law, it’s not just important what you say, but to whom you say it. Notwithstanding the fact that the “reasonable person” standard is the basis for evaluating an advertising claim – i.e., what does the claim communicate to the reasonable person – who that “reasonable person” is matters a lot. That doesn’t just mean that if you’re targeting children, the “reasonable person” is a kid.  It also can mean, as in this case, a patient versus a doctor. 

This issue was at the heart of a dispute between Eli Lilly, as challenger, and Novartis Pharmaceutical, the advertiser.  At issue were both physician and patient-directed advertising for Novartis’ breast cancer treatment drug, Kisqali, in which Novartis touted the results of a recent clinical trial and survival data.  The challenger argued that the survival benefit claims in the advertiser’s materials went beyond merely reporting the results of its clinical trials and but, instead, conveyed false and misleading messages about the efficacy of the Kisqali treatment.  Specifically at issue was the following claim:  “Only drug in class with consistently proven overall survival benefit in HR+/HER2- metastatic breast cancer.” * * “across three phase III trials”.  The details of each study were included in the materials, along with clinical indications for Kisqali and safety and other information.

NAD examined this claim from the perspective of both a lay audience (prospective patients) and a medical audience (oncologists and other health care professional). As to laypeople, NAD "was concerned that most consumers do not have the medical knowledge or experience to understand the nuances of clinical trials. They may not appreciate that the results of a clinical trial may be influenced by a variety of factors apart from the quality and efficacy of the tested drug, such as trial design, patient population characteristics, interactions and nature of adjuvant drugs, etc., and as such, they will not understand that outcomes across trials are difficult to compare. Further, the lay consumer will not understand that achieving statistical significance across three clinical trials does not in and of itself establish superior efficacy to other drugs which have proven effective in a smaller number of trials.” 

Notwithstanding the fact, as argued by the advertiser and accepted by NAD, that cancer patients today have more tools to learn about and engage with their treatment plans, “even the totality of resources available to them cannot bridge the knowledge gap between a lay person and an oncologist in the context of understanding the nuances of clinical data and the science behind it.”  Accordingly, NAD determined that, for a lay audience, the advertising communicated a claim that the drug could provide superior survival benefits over other drugs in class, a claim not supported by the evidence in the record.  Therefore, NAD recommended the claim's discontinuance in consumer-directed materials.

By contrast, NAD determined that the audience of the doctor-directed brochures could more readily determine that the “best in class” comparative claim was only as to clinical data points and not an implied claim of overall superior efficacy.  As NAD noted, it has “long recognized that health care providers and specialists are a sophisticated audience and are better equipped to decipher the advertised results of clinical data than the general consumer, especially when provided with appropriate context and detail thereon.”  Such an audience could “understand that although the achievement of a statistically significant survival outcome in more trials than its competitors is a promising result, it is not conclusive that Kisqali provides superior survival benefits or superior survival benefits to all classes of patients with HR+/HER2 metastatic breast cancer.”  Accordingly, NAD determined that the claim communicated to the health care professionals was simply that Kisqali was unique in achieving a statistically significant overall survival benefit across Novartis’ three phase III clinical trials, a claim Novartis could support.  Therefore, NAD did not recommend modification or discontinuance of the claim in doctor-directed materials.

This case addresses a very specific, albeit critically important, area of advertising: claims about the efficacy of a certain drug in clinical studies for stage IV (metastatic) breast cancer.  However, the principle at issue is a significant one: know your audience and what it is likely to understand and take away from your claims because as an advertiser, you are responsible for all claims reasonably communicated to your target audience, even those you may not have intended to communicate. Further, consider your target audience’s level of sophistication about the product or service at issue, because that can depend on many factors, including age and education, but also experience and employment. The more important the claim and the product and service at issue, the more important this determination. 

Engaging in this critical exercise before finalizing and releasing materials to the public should always be part of an advertiser’s protocol.

NAD/CARU Case Report #7137 (January 2023)