San Francisco partners J. Dominic Campodonico and Andrew Cary, and associate Gene Kim authored a chapter in the recently published DRI book titled, “FDA Basics for the Drug and Medical Device Lawyer.”
The book provides detailed insight into a variety of pertinent topics that are instrumental to litigation involving pharmaceutical and medical device products. Campodonico and Cary were asked contribute to the book given their extensive background handling complex matters involving regulations promulgated pursuant to the Federal Food, Drug, and Cosmetic Act. 21 U.S.C. § 301, et seq. With assistance from Kim, they wrote a chapter titled, “Advertising and Promotions,” which provides instruction on applicable regulations and case law from which readers can learn about the ramifications of purported misbranding and off-label marketing. The chapter examines enforcement mechanisms used by the government to ensure regulatory compliance and also reviews possible defenses to governmental actions.
“It was a privilege to be asked to contribute to this informative reference guide for drug and device litigators,” Campodonico said. He added, “DRI is to be commended for coordinating the publication of this book which will benefit practitioners and those interested in learning about pharmaceutical and medical device litigation.” Cary added, “Understanding the regulations regarding the advertising and promotion of pharmaceutical and medical device products is essential for those attorneys who work for or represent pharmaceutical or medical device companies. Our chapter provides a solid framework for those individuals trying to understand how these complex regulations work.”
For more information, click here. To view the table of contents, click here.
DRI is the international membership organization of all lawyers involved in the defense of civil litigation. DRI is committed to: enhancing the skills, effectiveness, and professionalism of defense lawyers; anticipating and addressing issues germane to defense lawyers and the civil justice system; promoting appreciation of the role of the defense lawyer; and improving the civil justice system and preserving the civil jury.
Campodonico has nearly 20 years of experience serving as co-national litigation coordinating counsel, regional counsel, and local counsel in mass tort litigation involving manufacturers and distributors of a variety of pharmaceuticals, medical devices, and related products. He also assists clients with high-stakes matters that frequently occur simultaneously with product liability litigation, such as risk management, compliance, and investigations. Campodonico is a member of DRI and currently serves on its Membership Committee.
Cary specializes in representing businesses and individuals in a broad range of simple and complex litigation matters, including cases involving drug and medical device product liability, regulatory issues, toxic tort matters, business disputes, breach of contract and professional liability. He also spends a significant amount of time consulting companies on complex electronic discovery matters and is co-chair of the Gordon & Rees E-Discovery Practice Group.
Kim represents multi-national manufacturers and distributors of pharmaceuticals and medical devices in a broad range of complex litigation matters, including product liability and commercial litigation.