Warnings and Instructions—Part 1
By Kenneth Ross, Of Counsel to the Minneapolis office of Bowman and Brooke LLP
As product liability law has evolved over the years, three defects have been identified as the main components of a product liability lawsuit. These are manufacturing defects, design defects and defects in warnings and instructions. The test for determining when there is a manufacturing defect is objective. However, the test for defects in design and warnings and instructions is very subjective and based on reasonableness factors to be decided by the jury.
Therefore, determining when there is a duty to warn or instruct and how far that duty extends is one of the more difficult questions to be answered by any manufacturer.
Basis of the Duty
The policy justification for the duty to warn is that manufacturers are better able to anticipate what dangers are inherent during the use of their products and in a better position to warn of these dangers. This is consistent with the move away from the concept of “let the buyer beware.”
The law’s goal is to encourage a balance of product safety and utility while enhancing the goal of risk reduction without eliminating the manufacturer’s incentive to produce useful products. It is much easier and cheaper to warn about hazards in a product than it is to design out the hazard or provide a guard. Therefore, it is in the best interests of society, especially consumers, that warnings be considered legally sufficient instead of higher priced products that incorporate safety devices or features meant for the few careless people that don’t follow warnings and instructions.
Basic Duty
A manufacturer has a duty to warn where:
- The product is dangerous
- The danger is or should be known by the manufacturer
- The danger is present when the product is used in the usual and expected manner
- The danger is not obvious or well known to the user
Another way to state this is that there is a defect when reasonably foreseeable risks of harm posed by the product could have been reduced or avoided by the provision of reasonable instructions or warnings and the omission renders the product not reasonably safe.
There is an interrelationship between adequate design and adequate warnings. For this article, we will assume that the manufacturer designed the product as safe as necessary and that hazards remain. Most products have residual hazards and need warnings either on the product or in the instructions.
Difference between Warnings and Instructions
Instructions inform persons about how to use and consume products safely. Warnings alert users and consumers to the existence and nature of product risks. With this combination of information, consumers and users can prevent harm by following the warnings and instructions during use or consumption or by choosing not to use or consume the product.
Warnings are usually contained in labels attached to the product or in hang tags that are attached to the product but are thrown away after purchase. Warnings can also be included in instructions that accompany the product.
Generally, warnings tend to be negative statements about things not to do or affirmative statements about things always to do. Instructions tend to describe in more detail how to do something safely and correctly.
The safety information on warning labels attached to the product can be a mix of affirmative, negative or instructional information. The same is true for safety information in instructions.
Determining Risk and Whether to Warn
During the design phase, manufacturers should do some sort of a risk assessment. This assessment identifies possible hazards with using the product and quantifies the probability that this hazard will occur and the severity of the harm that will be suffered if it occurs.
When this is completed and the product’s design has been established, it should be easy to identify residual risks that need to be warned about. If the risk is not sufficient, then maybe no warning is necessary. There are no rules to tell a manufacturer when the risk is too small to warn. Or, if the risk is not reasonably foreseeable, then maybe no warning is required.
If the risk is obvious, a warning may not be needed. But this must be done carefully because the risk and the probability and severity of harm may not be obvious to some potential product users.
In that case, the manufacturer needs to make a rational judgment as to whether a warning is necessary. Unfortunately, there are very few clear guidelines in this area. This is one reason why many manufacturers warn about too many hazards including small ones and obvious ones.
Once a warning is created, however, the guidelines, standards and law are a little clearer. But making this initial decision can be tough and one that should not be done without legal counsel experienced in the area of warnings. In addition, a manufacturer may decide to add the safety information to the instructions but not to the on-product warning label. Is that sufficient? Again, there are no rules and a jury gets to decide if the manufacturer was reasonable.
Adequacy of Warnings—The Law and Standards
Once the decision has been made to warn, the manufacturer needs to determine whether the warning is adequate. The law has said that a warning is legally adequate if:
- It is in a form that could reasonably be expected to catch the attention of a reasonably prudent person in the circumstances of the product’s use
- The content is of such a nature as to be comprehensible to the average user
- It conveys a fair indication of the nature and extent of the danger to the mind of a reasonably prudent person
A statute in Louisiana defines an adequate warning as follows:
“Adequate warning means a warning or instruction that would lead an ordinary reasonable user or handler of a product to contemplate the danger in using or handling the product; and either to decline to use or handle the product or, if possible, to use or handle the product in such a manner as to avoid the damage for which the claim is made.”
Despite these nice definitions, terms such as “reasonable user,” “fair indication” and “reasonably be expected to catch the attention of the user” make it clear that the jury gets to decide the adequacy of warnings. Also, the cases have not been particularly helpful because there are so many variables with the hazards, the avoidance procedures and the readers of the warnings. Is the reader educated, uneducated, skilled, unskilled and illiterate or do they have poor reading skills, etc.?
On the positive side, there are U.S. Standards (one of them is referred to as ANSI Z535.4) for designing warning labels that, if followed, will result in labels that look pretty much the same. These labels use a signal word—DANGER, WARNING or CAUTION—as well as possibly a pictorial or symbol, and then text. The text is supposed to describe the hazard, the probability of harm, the severity of the harm and how to avoid the harm.
Beyond that, the standards do not tell a manufacturer how to determine if a warning is required and what language or picture to put on the label. For that, the manufacturer needs to make some important decisions. Again, because of the significant consequences from making a bad decision, consulting a lawyer experienced with developing warnings is imperative. A lawyer may not be necessary if you are adopting competitors’ labels if they appear to have been developed by competent people. But, it is still a good idea for competent label people to review the labels to be sure they apply to your product and are likely to comply with applicable laws and standards.
Who Do You Have to Warn
Certain purchasers, users and consumers need to be warned. But others who a reasonable seller should know will be exposed to the product or the hazard may need to be warned. So, the janitor who cleans up at the end of the day may need to be warned about hazards he may encounter while cleaning up around a dangerous machine. And the adequacy of the message may be different for the janitor and the machine tool operator who understands the technical terms associated with the machine.
You may only need to warn an intermediary such as an employer and not the employee. You may need to warn a reasonably foreseeable bystander. There are no clear rules other than to say that reasonableness in the circumstances is the standard.
Other Considerations
Difficult issues remain that must be decided by the manufacturer. How big should the label be? Where should it be placed? What kind of material should it be made of? How should it be attached? Should any language other than English be on the label? Should the warning on the label be repeated in the instructions?
Conclusion
This area is dangerous because it is so easy for a plaintiff to argue that the manufacturer should have added a few more words and the accident would not have happened. The remedy is cheap—add a few more words—and it may be hard to defend given a serious injury and sympathetic plaintiff.
As a result, creating new warnings and instructions (or updating your current warnings and instructions) should not be done without first obtaining adequate assistance from legal counsel and engineers and label suppliers that know how to design and produce labels and manuals that comply with any applicable laws and standards. Once the labels and manuals have been developed correctly, it is easy to update or modify them in the future.
If you need expert guidance in the development of warning labels and instructions, contact Industramark. With a dedicated staff and years of experience in label compliance, Industramark can help make sure you’re meeting your duty to warn.