Major legal reforms are set to radically change the liability risks for drug and device manufacturers and suppliers in Europe. This session will zoom in on the recently adopted EU Product Liability Directive, which is infinitely more complainant-friendly, including by expanding the scope of claims that can be brought and range of damages as well as by making it easier for claimants to prove their case. The new Product Liability Directive sits alongside the EU’s new class action regime. In addition, new comprehensive rules concerning AI, corporate sustainability, circular economy and greenwashing create additional liability risks. This session will focus on helping life sciences leaders understand these developments – and specifically the compliance challenges and litigation risks posed to their companies as a result – and will provide some actionable steps companies can start implementing to lower their risks and improve compliance. The major product liability reform in Europe will be juxtaposed with the existing US litigation and product liability landscape with the aim of identifying both challenges and opportunities for life sciences companies, necessitating adept navigation of regulatory compliance and product liability risks.

This is Part 5 of a six-part series. Part 1, 340B Program: Update on Current Developments is taking place on November 12, 2024, Part 2, How the toughened up, amended Fed. R. Evid. 702 has been faring is taking place on November 12, 2024, Part 3, New Rule 16.1 on MDLs is taking place on November 13, 2024, Part 4, PFAS Litigation in the MedTech Industry: Key Cases and Emerging Trends is taking place on November 13, 2024, and Part 6, The New Frontier: AI in Product Liability Law is taking place on November 14, 2024.

Each of these programs are 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 Delaware, Florida, 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.