Sectors

Litigation & Regulatory Support

Setting the Standards: Methodological Expertise and Impeccable QC

NAXION has a long history of developing data for use by federal agencies and was one of the first research organizations to provide survey data admitted as evidence in a US court of law over 50 years ago.

NAXION’s reputation as both methodologically authoritative and operationally painstaking explains why we have long been a trusted source of evidentiary data and survey-based support for public policy.

Our contributions to the field rest on multidisciplinary expertise in survey methods and statistics, represented by a team of nationally recognized leaders in behavioral science research. NAXION’s reputation in the field also reflects the consistent level of operational excellence needed to produce valid, generalizable public opinion data and market-tested predictive simulation models.

Expert Testimony Under the Lanham Act

For well over a half-century, since the earliest application of survey science to litigation in US Federal Courts, NAXION has been conducting survey research on behalf of both plaintiffs and defendants to test claims of deceptive or misleading advertising, gauge the presence of secondary meaning, test genericness, and estimate likelihood of marketplace confusion or dilution based on confusingly similar trademarks. Our experience includes survey evidence and expert marketing testimony in the context of FTC and USPTO matters. We are also experts in the proper use of choice-based modeling to measure the incremental impact of various product or service attributes on willingness to purchase.

We offer a coherent consulting approach in Lanham Act cases supported by four sturdy pillars:

Seamlessly integrated survey design and implementation, including exceptional oversight of panels and other sample sources

Strategic consulting to major brands on course-of-business marketing problems, the basis for expert marketing testimony

Wide-ranging experience supporting litigation strategy, including the appropriate role for various kinds of analyses and data sources

Extensive experience providing deposition and courtroom testimony in the context of patent litigation

Devising and Supporting a Competitive Claims Strategy

NAXION also maintains an active practice providing consulting support to clients who seek to develop a competitive claims strategy, including a systematic framework that can be used collaboratively by marketing stakeholders and in-house counsel to risk stratify and prioritize claims. Our work takes a strategic view of relevant claims options including criteria relevant to support claims, likelihood of achieving threshold levels of substantiation, marketing leverage associated with various claims, and long-term sustainability.

Regulatory Support for Health and Public Safety Policy

NAXION maintains an active practice supporting FDA oversight of the pharmaceutical and tobacco industries, based on its exceptional command of survey science and a suite of forecasting tools used for the purposes of projecting health and public safety impact of product introduction or modification.

With the initiation of FDA’s Risk Evaluation and Mitigation Strategy (REMS) mandate, NAXION’s foundational work helped set monitoring protocols to confirm correct and fully informed use of implementation norms and standards used to monitor drugs designated as having special post-market oversight requirements. In other pioneering work commissioned by a pharmaceutical industry consortium, NAXION’s published survey and experimental data regarding consumers’ interpretation of drug ads was submitted to FDA in support of its emerging guidelines on DTC advertising. The firm is also actively involved in collecting data to help FDA assess the public health impact of new tobacco products.

Experienced and Authoritative Practitioners

The leader of the firm’s litigation practice is Susan Schwartz McDonald, Ph.D., NAXION’s CEO, who has testified in many US federal districts as both a marketing expert and a survey expert on matters concerning trademark strength, trademark infringement, and deceptive advertising. Her testimony has addressed a very wide variety of products, including diverse consumer goods as well as B2B categories in which surveys may not be feasible. Her extensive professional history of consulting in the life sciences sector – including commercial strategy and marketing for biopharmaceuticals and devices – confers a unique expertise in Lanham Act cases involving the life sciences industry and its diverse stakeholders.

Susan is the author of the chapter on secondary meaning in “Trademark and Deceptive Advertising Surveys: Law, Science, and Design, Second Edition,” Shari Seidman Diamond and Jerre Swann (Eds.) 2022.

The leader of the firm’s regulatory practice is Michael Polster, Ph.D., a neuropsychologist, methodologist, and marketing consultant, whose research activities in the service of FDA oversight over the past few decades have been innovative and far-reaching. Michael’s unique skill set, reflecting his cross-functional role in both the Life Sciences and Litigation practices, is the basis for work in Lanham Act cases concerning healthcare advertising claims and consulting support for clients seeking to validate or challenge competitive claims.