Publications
Crisis Management: Steps You Can Take Now to Be Prepared, Part I
Imagine you learn of a serious adverse event that involves your product. Upon receiving notice of the occurrence, your company is obligated immediately to perform certain activities,...
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...
You’ve Been Sued, Now What?
Introduction Being the recipient of a lawsuit is unsettling and disruptive to any company. Not only can it be expensive to defend against, but the process itself can be complex,...
Who’s Driving This Bus? Issues Involving the Tripartite Relationship
The tripartite relationship describes the dynamic between an insurer, an insured, and a defense attorney hired by the insurer to defend the insured. Its scope and defense counsel’s...
Depositions in Life Sciences Products Liability Cases
Introduction Modern litigation is composed primarily of the “discovery” process, and the most visible—and arguably most important—component of the discovery process is the deposition....
The Ethical Oversight of Clinical Trials: Institutional Review Boards
Abstract: Clinical trials—medical research studies involving people—play an essential role in the advancement of medical science and technology. The information obtained from clinical...
Effective Supply Chain Management for Medical Device Shipments
Medical device manufacturers face a daunting challenge in today's market. In addition to understanding stringent government regulatory requirements and FDA-mandated current Good...
Insurance Issues that Arise in Products Liability Litigation for Life Sciences Companies
Astute life sciences companies purchase products liability insurance to assure the protection of their assets and reputations in the event a claim arises alleging their product caused...
Document Management: How Life Sciences Technology Companies Can Protect Themselves
Product Liability is a Significant Risk to Life Sciences Technology Companies While some product liability lawsuits grab media attention, 90% are settled out of court through agreements...
Do distributors require professional liability insurance coverage in addition to products liability insurance coverage?
Question:Do distributors require professional liability insurance coverage in addition to products liability insurance coverage? Answer: No, at least not “professional...