Publications
Adverse Event Reporting
What should a medical device sales representative do if an adverse event occurs during a procedure?
Question: What should a medical device sales representative do if an adverse event occurs during a procedure? Answer: Medical device sales representatives must report adverse...
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...
The Learned Intermediary Doctrine
The Doctrine The Learned Intermediary Doctrine provides that a drug or medical device manufacturer has no legal duty to warn consumers of a drug or medical device’s harmful side effects...
Medical Device Reports (MDRs)
The Food and Drug Administration ("FDA") requires medical device companies to report fatal or serious incidents - or potentially fatal or serious incidents - associated with the use of...