Ripped from the Headlines: Medmarc’s Risk Management Team Discusses Lessons Learned from Life Sciences in the News and What to Watch for in 2019

Previously Recorded on January 16, 2019

In this annual webinar, two attorneys in Medmarc’s Risk Management Department will break down some of the biggest headlines from the last year and discuss what life sciences companies can take away from these stories and what they should have their eyes on in 2019. Specifically, this webinar will discuss cybersecurity, opioids, OTC monograph reform, and the digital health pre-certification program. 

In this webinar, you will hear: 

  • The latest in opioid litigation and potential new targets for plaintiffs in the opioid epidemic
  • FDA’s newest cybersecurity guidance and what it means for device makers
  • The potential upending of the over-the-counter drug monograph system
  • FDA’s digital health pre-certification program and the congressional scrutiny in its future

Courtney S. Young, Esq., is the Senior Attorney for Risk Management for the Medmarc Insurance Group.  Her primary responsibilities include the development of resources on products liability avoidance and regular correspondence with brokers, policyholders, and underwriters in efforts to evaluate and mitigate products liability risk.  Ms. Young publishes articles on products liability risk management for industry organizations, such as IMDA, and publications, such as Life Sciences Panorama. She also maintains a blog on products liability issues for the life sciences industry, on which she discusses recent products liability litigation, FDA regulatory activity, and industry news.

Ms. Young received her law degree from the George Mason University School of Law and is a member of the California and District of Columbia Bars.  She is also a graduate of the University of California, Santa Barbara, where she received a BA degree.

Kathryn Tarallo Klaus, Esq., is a Risk Management Attorney for the 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, she 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 now brings this experience in navigating the FDA landscape to Medmarc, where she works with colleagues in-house, as well as with policyholders, in developing and strengthening regulatory compliance strategies in an effort to mitigate products liability losses. 

Ms. Klaus is a graduate of The Catholic University of America, Columbus School of Law, and the College of the Holy Cross.

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