Update Nov Dec 2013 - (Page 37)

FDLI Activities Photography from FDLI's 2013 Advertising and Promotion Conference by Valter Schleder off-label promotion issues, including those addressing training requirements, monitoring requirements, and other areas of risk, such as research and authorship. Weaver's remarks continued the discussion of risk assessment in corporate integrity agreements. He described the importance of using a systematic approach to provide a broad perspective of individual risk, comparative risk and an overall risk profile. He explained that a company should implement this approach by identifying and analyzing key potential compliance risk areas while also developing plans and controls to mitigate the identified areas. Weaver emphasized that the CIA is not a standard agreement and is uniquely tailored to each company's portfolio and needs. Common elements may include a proactive approach to identifying risk before conduct occurs, with a central focus on sales and marketing activities. He also noted that risk mitigation plans are a common element, observing that not all risks are created equal. In identifying sales and marketing risks, a risk assessment process should take into account risks associated with the product, the company and the external environment. Weaver further suggested that companies should develop planning, tracking, reporting, and points of accountability and dates for completion that respond to their highest risk activities. Through cross-functional participation in these plans, companies will be able to get a full picture and use a broad, inter-departmental approach to find and address risk areas. Weaver FDLI concluded with the message that the process of planning for and mitigating risk requires creative thinking. Brown shifted the discussion to the state level with a presentation on false advertising class action litigation under state-level "little FTC Acts". Citing to the expanded use of the California "exposure" test in other states, Brown described the trend of allowing class action suits with no demonstrated reliance or injury in fact. He explained that "little FTC Acts" use the same language of deception and unfairness as the federal Act and that, with respect to advertising, deception is the most important issue. State juries, however, are not always instructed as to the FTC's definitions of deception and unfairness. Further, without reliance as a required element, these cases are easy to certify, posing an advantage for plaintiffs. In some states, Brown stated, the injury-in-fact requirement is circumvented by claims of price inflation, a "fraud on the market" theory. With no requirement to prove reliance, there is no need to prove that the consumer was injured in fact. Therefore, these cases are often decided on the basis of materiality. As Brown noted, class actions are a procedural rule-the plaintiff must prove his case, and in proving his case, he must prove the case of every other member in the class. Nevertheless, without states' requiring evidence of actual damage to the consumer, Brown warned, the risks associated with little FTC Act actions is larger than in the past and these cases are much harder for defendants to win. FDLI November/December 2013 Update 37

Table of Contents for the Digital Edition of Update Nov Dec 2013

Update Nov Dec 2013