Data obtained in support of litigation testimony and regulatory compliance require authoritative perspectives on methodology and exceptionally high levels of operational excellence. NAXION’s long, respected history as a source of guidance to adjudicating and regulatory bodies reflects its commitment to both precepts. The firm has provided data to inform public policy for over 75 years, and survey data in support of courtroom testimony for nearly a half-century.
Expert Testimony under the Lanham Act and other Federal Litigation Requiring Survey Testimony
Susan Schwartz McDonald, Ph.D, NAXION’s CEO, leads its litigation support practice and testifies regularly, as both a marketing expert and a survey expert, on matters concerning trademark strength (secondary meaning, genericness, likelihood of confusion, dilution) as well as false and deceptive advertising. All surveys she conducts are implemented by a NAXION team with extensive experience in litigation support and keen appreciation for the specialized QC requirements of data developed as evidence for courtroom proceedings. Susan has also conducted research considered by FDA, FTC, and ITC in their oversight. Her testimony has spanned a very wide variety of products, although her work in healthcare marketing and drug development confers a unique expertise in cases involving drugs and medical devices.
In addition to work in support of Lanham Act proceedings, Susan has been involved in patent cases, offering methodological expertise on methods for assessing the value of product technologies and features in accounting for sales.
Surveys in Support of REMS and Other Aspects of FDA Oversight
Michael Polster, Ph.D., SVP of NAXION, oversees its REMS practice which involves development of survey data to monitor physician and patient awareness of drug safety risks and (along with other senior members of the NAXION Healthcare & Life Sciences practice) consults to companies in the development of specialized patient/consumer product inserts that can be certified to FDA as clearly understood.