Publications
MTLI: Education of the Industry, by the Industry and for the Industry
The Medical Technology Learning Institute (MTLI) is the education department of AdvaMed, an association whose member companies produce nearly 90 percent of the medical devices, diagnostic...
The Origins of Products Liability
Introduction Products liability is one of the most important U.S. legal developments in the last 100 years for numerous people and entities: consumers, product-users including hospitals...
Claims Case Study: Medmarc Helps Global Distributor Avert $8 Million Lawsuit
Case Study: Medmarc Helps Global Distributor Avert $8 Million Lawsuit Smart strategy from day one helped de-escalate a potentially devastating case. EXECUTIVE SUMMARY A physician claimed he...
Drafting Informed Consent Forms
The key objective of obtaining informed consent from a clinical trial participant is to ensure that the participant fully understands the nature and risks of the clinical trial. The informed...
Preemption Defense for Generic Pharmaceutical Companies
Generic pharmaceutical manufacturers recently received an historic victory from the highest court in the land. In Pliva, Inc. v. Mensing, the United States Supreme Court held that federal...
Selecting Employee Witnesses
Question:We are a small manufacturer of medical devices and have just been served with our first lawsuit. We have been asked by appointed counsel to select someone within our company...
Sales Reps and the Practice of Medicine
Question:When is a medical-device sales representative who is present in a clinical setting engaging in the practice of medicine? Answer: With today’s high-tech surgical...
Products Liability Litigation Challenges for Life Sciences Companies, Part I
Introduction The United States is widely regarded as the most litigious country in the world―and for good reason. The U.S. has the most lawyers per capita, and spends the most money—both...
Case Study: Which Way Do I Turn? Understanding the difference between professional liability & products-completed operations
There are more than 7,000 manufacturers of medical devices in the US, mostly small- and medium-sized enterprises, with more than 80% having fewer than 50 employees1. Many small life...