- Provide a formal record of all this stuff, as well as the for the design process. Once again, such records do not need to be verbose, legal documents; they need to simply record what has been done and why. Complete traceability is required with any product safety effort as an adjunct to product liability.
- And do, perform some type of Hazard / Risk analysis regardless of how simple the product is. This should include discussion of any inadequacies in form or function, all feasible misuses and component selection, as well as, production processes.
Note that both the European Union and the United States have the same hierarchy for reducing product safety risks: Whenever possible, the hazard must be eliminated in the design. When this is not possible, the risk of harm must be reduced through guarding or other protective devices. Only after these means have been exhausted should residual risks be addressed through warning and/or informing users of special training, procedures or protective equipment that must be used to avoid harm.
Manufacturers have a legal duty to provide adequate instructions (throughout the useful life of a product) in all cases and to warn of any dangers that would not be apparent to the average user. Some courts have imposed a duty to warn even with respect to open and obvious dangers. The duty to warn extends to all known dangers, as well as to all the dangers that ought to be known to the manufacturer on the basis of existing state-of-the-art technology. This leads us to…
- Product Labeling (on product and in manuals and literature) is as important as product design. A product may be defective even if it is neither defectively manufactured nor designed. The courts have long held that the failure to warn of a product's potential hazard is an inherent defect, invoking all of the trappings of product liability. There are four basic elements in a failure to warn case:
- The manufacturer knew, or should have known, the risk inherent in the product;
- There was no warning, or alternatively, the warning provided was inadequate;
- The absence of a warning made the product unreasonably dangerous;
- The failure to warn was the cause-in-fact or approximate cause of the plaintiff's injury.
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©2004, Richard M. (Dick) Haney
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