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 anything that was originally contemplated when products liability law first developed.
This expansion has impacted medical-device manufacturers that create products which are usually safety-critical and difficult to use properly and safely.Device manufacturers have an added burden in that they must comply with the various laws, regulations, and guidances from the U.S. Food and Drug Administration and foreign government authorities, as well as with consensus standards created by groups such as the American National Standards Institute (ANSI), the Association for the Advancement of Medical Instrumentation (AAMI), and the International Organization for Standardization (ISO).
Government regulations concerning product safety of consumer products (including some medical devices used by consumers at home and in health care facilities) are also proliferating around the world.Australia and Canada adopted new product safety laws in 2011.Manufacturers need to be aware of all of these requirements, especially those requiring reports of adverse events to government authorities, which could possibly trigger a corrective action in one or more countries.
Unfortunately, even if device manufacturers comply with such requirements, they are generally not totally protected from liability in the event of an incident resulting in injury, death, or damage.Therefore, in order to minimize or prevent liability, they need to understand the legal requirements, standards, and best practices within the medical device industry, understand the legal risks they face, and understand how to design, manufacture, and sell reasonably safe and compliant products, as well adequately monitor their products after sale and comply with any resulting regulatory requirements.
The goal of any medical-device manufacturer is to prevent or minimize the possibility of incidents, ensure compliance with all applicable safety and technical requirements, and make themselves and their products defensible in the event adverse incidents or alleged non-compliances occur.
This series of articles will briefly describe the legal requirements and techniques for minimizing liability.While the articles will include some discussion of applicable regulatory requirements, it is not the intent of these articles to deal with such requirements in any comprehensive way.In addition, because common law in the United States is a creature of states and thus varies widely from state to state, the legal discussion of U.S. state law will be very general.
Manufacturers, product sellers, and everyone else in the chain of production and distribution need to understand the basics of liability and how to protect themselves.These articles will describe in some detail the law of products liability, especially the three kinds of defects that may be alleged in any case, and several aspects of a products liability case.
There will be an article discussing the different parties that can be sued in products liability and one describing contracts and how you can protect yourself.There will also be articles discussing how you can protect yourself against the two main kinds of defects—design defects and defects in warnings and instructions—as well an article on how a company can organize itself for optimal product safety.
Next, there are articles describing in detail the law and management techniques for preventing liability in one of the most serious areas—post-sale duties—and finally, articles on how to deal with documents.
Given the necessarily general nature of the information that will be provided in these articles, it is important that you consult with Medmarc Loss Control and experienced products liability and regulatory counsel before you undertake any actions related to the information contained in these articles.
Kenneth Ross is Of Counsel to the Minneapolis office of Bowman and Brooke LLP where he practices in the areas of product safety and liability prevention and advises manufacturers, product sellers and insurers on ways to identify, evaluate and minimize the risk of products liability and contractual liability. These guides do not constitute legal advice and are very general. You should consult competent legal counsel or Medmarc Loss Control before acting on any of the information in these guides.
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