Emerging Biopharmaceutical Compliance Roundtable

On August 23, 2021, Teresa Griffin, Mary Hershewe and Mike Zogby presented on risk assessment and litigation preparedness issues to the Emerging Biopharmaceutical Compliance Roundtable. Mary Devlin Capizzi introduced the panel to the roundtable, which is comprised of regulatory, compliance and data privacy in-house counsel at biopharmaceutical manufacturers throughout the world.

The presentation, “Risk Assessment and Product Liability Litigation Insights for Companies Introducing a Pharmaceutical Product Into the Marketplace,” provided an introduction to litigation theories and claims for companies that are developing and marketing pharmaceutical products. Teresa, Mary and Mike focused on recent litigation activity in the pharmaceutical industry, discussed common product liability claims and defenses, and provided tips and best practices relating to company documents and data, communications and messaging, detail representative and KOL training, clinical trials, marketing messages, and labeling considerations. The team examined several case studies demonstrating the impact of documents requiring explanation in litigation, spoliation claims, trial theories, and how reptile tactics are being used to increase damages awards.

Takeaways included having a strong offense as the best defense, keeping clear lines between business and marketing, always maintaining professionalism during internal correspondences, and using counsel to prepare company and employee witnesses for reptile and rambo tactics.