Life sciences companies are required to maintain a significant amount of documentation, from R&D and production records to call notes andcorrespondence with customers. When it comes to defending a product liability claim, documents can either bolster the defense or contain a “ smoking gun”. In this webinar, attendees can expect to learn about how product liability claims arise, how documents can impact claims brought under each theory, and best practices and considerations for documentation in day-to-day work.
Speaker - Kathryn Tarallo Klaus, Esq.
Kathryn Tarallo Klaus, Esq., is the Senior Risk Management Attorney, FDA Specialist, with Medmarc Insurance Group. Her focus is on legal matters faced by participants in the life sciences industry, specifically FDA regulatory compliance. She began her career with FDA’s Center for Biologics Evaluation and Research, where she worked on the Broad Spectrum Autism litigation under the National Childhood Vaccine Injury Act.
After leaving FDA, Kate worked in private practice with two national law firms, counseling clients through all phases of the regulated product life cycle, including development and approval, manufacturing, labeling and advertising, and post-market concerns and enforcement. She has advised clients regarding defense against regulatory enforcement actions, including FDA 483 Inspectional Observations, Warning Letters, U.S. Customs detentions, product recalls, and DHHS OIG exclusion proceedings. She has also counseled clients through all health law-related aspects of major transactions, from conducting facility and records compliance auditing during due diligence investigations, to federal and state licensure requirements, and the development and implementation of improved compliance programs post-closing.
She brings this experience in navigating the FDA landscape to Medmarc, where she works with colleagues in-house, as well as with policyholders, in developing regulatory compliance strategies in an effort to mitigate products liability losses.
Kate is a graduate of The Catholic University of America, Columbus School of Law, and the College of the Holy Cross. She is a member of the Massachusetts Bar.