Publications
Litigation for Life Science Companies: Aspects of Litigation That Should Affect How You Run Your Business
The prior twelve articles in this series have focused on products liability in general and the various aspects of designing, making, and selling medical devices. These articles pointed...
Post-Sale Duties: FDA Law and Regulations
Introduction As described in the previous article, manufacturers of medical devices sold in the United States have two bodies of laws to consider after sale: the common law of product...
Marketing Defects and Warranties
Manufacturers of medical devices and providers of services concerning these devices can be held liable for injury, damage or economic loss suffered by a purchaser and a third party such...
Introduction to Products Liability 360
Products liability has created problems for product manufacturers, sellers and product-users for centuries. More recently, however, there has been an expansion of liability well beyond...
Contracts
Introduction The supply chain for medical devices and diagnostic equipment can be fairly complex.Raw material suppliers sell to component part manufacturers who sell to final...
Proactive Document Management for Device Manufacturers – Part 2
Part 1 of this article discussed the importance of documents in designing and manufacturing products and how the existence of or lack of drawings, plans, and other records has hurt...
Manufacturing and Design Defects
Introduction Manufacturing defects were the original defects envisioned when strict liability was first conceived in the early 1900s. Strict liability was developed in the context of...
Post-Sale Duties: Common Law and Post-Sale Safety Management
Introduction Merely manufacturing, designing and selling a safe product may not satisfy a product manufacturer’s legal duties. Many years ago, courts held that a manufacturer has a duty...
Defects in Warnings and Instructions
Introduction As the common law of products liability has evolved over the years, three defects that exist in the product at the time of sale have been identified as the main components of...
Product Safety Management
Introduction The risk of accidents and products liability can never be completely eliminated. However, potential liability can be minimized by reducing the probability of accidents...