Publications
Warnings and Labels
Unique Device Identifier (UDI) Fundamentals
Question: What can life sciences companies expect from the UDI program? Answer: Although many in industry may be quick to view the UDI as only a “labeling rule,” the impact of...
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...
Products Liability Risks of Medtech Websites
Question: What are the regulatory and products liability risks associated with medtech companies' websites and online activities? Answer: To be a viable going concern today, it is...
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...
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 Labeling Requirements
Question:How do product labeling requirements differ between medical devices and pharmaceuticals? Answer: The FDA has stringent regulations regarding the labeling of medical...
Off-Label Promotion
Question:What risk management precautions should a firm take if significant sales are derived from off-label use of its drug or device? Answer: Promoting medical devices and...