Federal preemption has long been a powerful defense for medical device and generic drug manufacturers facing product liability claims, but this session dives into two cutting-edge questions surrounding novel applications of preemption: Will biosimilar manufacturers gain the same or similar preemption protections as their generic counterparts? And can makers of 510(k) medical devices cleared via the de novo pathway leverage preemption defenses? Drawing on their extensive experience mounting preemption defenses, our presenters will offer strategic insights and predictions on how the courts may address these pivotal issues. Join us for an engaging discussion at the forefront of biopharmaceutical and device law.

This is Part 11 of a eleven-part series. Part 1, The New EU Product Liability Directive: A Game-Changer for Biopharma, Medtech, and Digital Health Companies, is taking place on November 3, 2025, Part 2, Life Sciences Early-Stage Dealmaking: Trends and Diligence Strategy, is taking place on November 3, 2025, Part 3, Navigating the Evolving Frontier of Women’s Health and Fertility Treatments, is taking place on November 4, 2025, Part 4, From Pharma to Produce: California’s Evolving Tort Terrain, is taking place on November 4, Part 5, AI and Life Sciences: A Collision Course, is taking place on November 4, Part 6, Recent Developments in Vaccine Product Liability Litigation, is taking place on November 5, Part 7, A World Without Government Pricing Programs, is taking place on November 5, Part 8, AI and Ethics: Navigating and Challenging Improper Use in Legal Proceedings, is taking place on November 6, Part 9, Hot Topics in Fraud and Abuse for Medical Device Manufacturers, is taking place on November 6, Part 10, Toxic Tort Litigation in the Life Sciences and Consumer Health Industry: Key Cases and Emerging Trends, is taking place on November 7.

CLE Information: This webinar is presumptively approved for 1.0 CLE credit in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas and West Virginia. Applications for CLE credit will be filed in Colorado, Delaware, Florida, Georgia, Ohio, and Virginia. Attendees who are licensed in other jurisdictions will receive a uniform certificate of attendance but Reed Smith only provides credit for the states listed. Please allow 4-6 weeks after the program to receive a certificate of attendance.