Alvin S. Weinstein
Weinstein Associates
Product safety consultants
Brunswick, Maine

 

The U.S. Congress, state legislatures, and legal commentators all are writing and rewriting legislation or modifying the legal principles that govern product-liability litigation. Michigan and Illinois already have new laws in place, and at least another dozen states are making changes. The American Law Institute also has proposed significant modifications to the product-liability law that likely will be adopted soon. And the Common Sense Products Liability Legal Reform Act that passed Congress last year, but was vetoed by the President, is scheduled to return this year.

The critical questions are what impact will these changes likely have on litigation, and what should manufacturers do to realize the greatest possible business benefit?

Peering into the crystal ball of product liability, it is highly unlikely any changes in the law can prevent a manufacturer from being sued. An injured person persuaded that a product was somehow responsible for the harm will file a lawsuit. The changes, then, can only make it more difficult for the plaintiff to make a case against the manufacturer, or enhance the manufacturer’s defense against the allegations.

The most significant modifications likely to have positive impact for the defendant are:
• Design defects will be judged solely by the principle of negligence and not strict liability.
• The plaintiff must demonstrate that a reasonable alternative design would have prevented or reduced the severity of the harm.
• Plaintiff’s failure to follow the defendant’s warning or instructions, if deemed adequate, will reduce or eliminate the award of the damages.

Let us analyze each of these from the manufacturer’s viewpoint.

Negligence Versus Strict Liability
Negligence theory is based on fault. The injured person has to show the manufacturer acted unreasonably in order to recover. The plaintiff must argue, first, that the product was in substandard condition — either mismanufactured, poorly designed, or had inadequate instructions or warnings.

Next, the plaintiff has to show that this alleged substandard condition caused the injuries. Finally, the plaintiff must demonstrate the manufacturer knew or should have known of the condition and then failed to take reasonable steps to eliminate it before selling the product. That is, the plaintiff has to prove fault or bad conduct by the manufacturer.

Negligence differs sharply from the legal theory of strict liability which, many commentators argue, has sent product-liability suits skyrocketing since it burst onto the scene in 1963. Strict-liability theory says, essentially, that anyone who sells any product in a defective condition unreasonably dangerous to the user or his property is subject to liability for physical harm caused, even though the seller has exercised all possible care in the preparation and sale of the product.

When the product design is alleged to be defective under strict liability, the question is not whether the manufacturer acted reasonably in designing the product (as it is in negligence), but whether the product as it functions in society is too risky.

If negligence principles, alone, take hold in the future for allegations of design defect, the manufacturer’s efforts will be tested by the standard of reasonableness and not by strict liability’s standard of societal expectations. The question at trial will be: Does the design create unreasonable risks of injury?

To answer this, the American Law Institute proposes a risk/utility analysis. This test determines whether a reasonable alternative design would, at reasonable cost, reduce the foreseeable risks of harm posed by the product, and if so, whether the omission of the alternative design rendered the product not reasonably safe. This phrase means the product contains unreasonable dangers, and only unreasonable dangers associated with a product can lead to liability.

Under the reasonableness test of negligence the jury must decide whether or not, on balance, the risks associated with the product outweigh its utility, and if so, whether there were reasonable, safer alternatives. Considerations to be addressed in such a risk/utility analysis are:
• The usefulness of the product.
• The availability of other and safer products that meet the same need.
• The likelihood of injury and its probable seriousness.
• The obviousness of the danger.
• Common knowledge and normal public expectation of the danger (particularly for established products).
• The ability to avoid injury by care in use of the product (including the effect of instructions and warnings).
• The ability to eliminate the danger without seriously impairing the usefulness of the product or making it unduly expensive.

This risk/utility analysis looks at a product at trial, after it has been alleged to be not reasonably safe. How can this help the manufacturer demonstrate that, at the time the product was designed, it was a reasonable one, that is, the design addressed all reasonably foreseeable risks and there were no reasonable design alternatives that would have made the product safer? To answer this question, we must consider the plaintiff’s need to demonstrate the existence of a reasonable design alternative.

Reasonable Alternatives
The second proposed change in the law requires the plaintiff to prove there was a reasonable alternative design that would have reduced or prevented harm. There is a crucial reason to consider the plaintiff’s burden of proof in alleging a design defect in concert with a risk/utility analysis during the product design. Quite simply, if the manufacturer had undertaken a comprehensive risk/utility analysis during the design, the plaintiff will literally be foreclosed from presenting a reasonable alternative design. To understand why, first recognize that the only thing the plaintiff wants to show is a design modification that would have prevented only the plaintiff’s injury and nothing more.

Of necessity, the plaintiff’s focus is narrow, restricted to what would have prevented the incident that is the subject of litigation. And it may well be that, from this perspective alone, there is a design alternative that would have prevented the risk of injury in question. The critical question, however, is whether the plaintiff’s proposed design alternative is reasonable, meaning one that reduces the reasonably foreseeable risks of harm without seriously impairing the usefulness of the product or making it unduly expensive. Through a risk/utility analysis undertaken during the design process, the manufacturer will have accounted for all reasonably foreseeable risks of harm, in contrast to the plaintiff’s narrow focus of accounting for only the one risk that injured him.

The manufacturer must be able to argue that, in balancing all reasonably foreseeable risks from all identified hazards, the plaintiff’s specific risk was addressed, and the design that emerged was a reasonable balance of the greatest utility with the least overall risk. As a result, the plaintiff is left without a reasonable alternative to the manufacturer’s actual design.

Ideally, the manufacturer will be able to argue, at trial, that the plaintiff’s proposed alternative design had been considered but was rejected for substantive reasons such as seriously impairing the product’s utility or increasing the probability of encountering at least equally, if not more, serious risks from other sources.

Consider This Example
Let us suppose that a tractor hauling a semitrailer has a collision that fractures the tractor’s right front leaf spring. This causes the right end of the front axle to move rearward, throwing the tractor into an uncontrollable right turn. As a result, it hits an embankment and overturns, leaving the driver permanently injured.

The plaintiff argues that the spring design was not sufficiently “crashworthy,” that it should have been more resistant to failure from impact, since collisions like this, although not caused by the vehicle’s design, are reasonably foreseeable. The plaintiff’s argument is that the collision forces were not excessive and that a reasonably designed spring would not have fractured. The plaintiff’s expert then shows a proposed spring design using significantly heavier gauge steel of a different alloy, and argues (correctly, we will assume) that had the spring been designed as shown it would not have fractured in this collision. The driver therefore could have retained control and would not have been injured.

Thus, argues the plaintiff, the original design was defective, since the proposed alternative design could have been produced at reasonable cost, would have reduced the foreseeable risk of harm in this incident posed by the original design, and the omission of the alternative design rendered the product not reasonably safe.

If the manufacturer had not undertaken a reasonably comprehensive risk/utility analysis for the spring in creating the original vehicle design specifications, about the only arguments that could be offered at trial to refute the plaintiff’s alternative design are that the plaintiff’s proposed spring would be heavier, slightly reducing available payload, and would cost more. It is unlikely the jury would be swayed by such arguments.

However, had the manufacturer followed the recommendations contained here, it would, as part of the vehicle design, have conducted a thorough, comprehensive analysis of how the spring’s design must be altered to withstand the impact between the loaded tractortrailer and a solid object at increasing closing speeds without failing. As the spring is designed to withstand these increasing impact loads without failure, the spring characteristics critical and necessary for vehicle handling (such as steering and reduction of vibration) will seriously erode.

This erosion can readily be shown to increase the potential for other, more serious risks of injury arising from the inability of the driver to control the vehicle properly under all foreseeable conditions. Further, if drivers are subjected to increased vibration and difficulty in controlling the vehicle, they will certainly suffer from increased fatigue, which will cause more accidents.

The point here is that the manufacturer, in contrast to the plaintiff, must show the need to balance many competing considerations to arrive at a reasonable design. A manufacturer which has undertaken a comprehensive risk/utility analysis should be able to show it attempted to design a spring that was even more impact resistant than that suggested by the plaintiff’s design alternative. However, to minimize the risks of injury arising from all foreseeable sources, the design on the truck was at the limit of both technological and economic feasibility. The final design was a reasonable balance of all of the competing considerations fundamental to spring design.

On the basis of having undertaken a comprehensive risk/utility analysis, the manufacturer can argue that the original design was reasonably safe even though it fractured as a result of the collision, and that there was, at the time of manufacture, no spring design that could successfully and reasonably balance all the competing considerations and still have withstood the impact load from the collision in question.

Such a comprehensive analysis would, undoubtedly, have included not only the plaintiff’s proposed design, but also many others that were considered and rejected to reach a reasonable balance in the design. Thus, the plaintiff’s proposed design was not a feasible alternative in that it would have increased the risks arising from other hazards.

User Communications
The third area that can have a significant impact for manufacturers is that of warnings and instructions. The Common Sense Products Liability Reform Act of 1996 shifts the burden of product misuse or abuse to the plaintiff, if the defendant has warned or instructed about the actions that caused injury. These communications, however, can be a defense only if they are adequate.

The basic hierarchy governing warnings in relation to product design is simple: The first design responsibility is to eliminate the hazard so it cannot cause injury. If unable to do that, the second choice is to guard against the hazard, placing a barrier between it and the user to minimize or prevent contact. As a last resort, and only if unable to eliminate or guard against it, warn against the hazard.

Manufacturers should not substitute warnings for effective design or guarding. The plaintiff showing a reasonable design alternative will likely defeat the defense claim that an adequate warning was provided.

Thus a warning must not be viewed as an add-on adhesive label to be kept out of sight so as not to mar product aesthetics. It really is an admission of the inability to design out, or guard against, the hazard. More important, the warning has to do what could not be done by design or guarding: prevent injury from the hazard.

The legal test of the efficacy of instructions and warnings is whether they are “adequate.” While the law has not defined the term with precision, case law indicates that legally adequate instructions and warnings must:
• Acknowledge the likely limitations of the users — for example, ability to read and comprehend.
• Be tested on a group representative of the user population to establish comprehension levels.
• Be located so they are likely to be seen and acted on before the hazard is confronted.
• Be likely to be seen under all reasonable environmental conditions.
• Have the right signal words.
• Be likely to last the entire useful life of the product.
• Be easily replaceable, if they are lost or misplaced, especially in the case of instructions.

Unfortunately, warnings and instructions rarely undergo evaluation and testing for adequacy. But unless manufacturers make reasonable attempts to establish that both warnings and instructions are adequate, through a reasonable testing program, little, if anything, can be offered to defend against the charge that the communications are inadequate. Without solid, well-documented evidence to refute the charge of inadequacy, the defendant cannot transfer the risk to the plaintiff as the proposed change in the law will allow.

Future Impact
It is unlikely that changes in productliability law will, in the near-term, significantly reduce the number of lawsuits or prevent a manufacturer from being sued. However, a manufacturer’s ability to mount solid defenses may reduce the plaintiff’s willingness to file suit.

The most important consideration in mounting a solid defense is to ensure the product is reasonably safe. This means undertaking a risk/utility analysis that results from the system design safety procedure described.

This process requires both funds and commitment, but the future payoff can be significant. Demonstrating that the product contained a reasonable balance of competing considerations, and that the process by which the product emerged was one of integrity and was important to the company shows the product is reasonably safe. Only reasonably safe products will end the lawsuit crush, and ultimately, perhaps eliminate the product-liability trip altogether.

Is a kitchen knife “reasonably safe”?
Under the reasonableness test of negligence, a risk/utility analysis determines whether or not the risks associated with a product outweigh its utility, and if so, whether there were reasonable, safer alternatives.

Consider the analysis of a kitchen knife, for example. First, there is little question the implement is extremely useful and desirable for a myriad of purposes within the home and other foreseeable environments. Next, there appear to be no other products on the market that meet the same need and are safer.

Unquestionably, there is a moderate to high likelihood of injury, but for the most part the level of seriousness is generally low to moderate. There is no question the hazard is significant.

The danger is obvious because the risk of injury from contact with the blade is well understood and generally anticipated by users, if the knife is not used properly. This leads to the next element, since most, if not all, injuries are avoidable if we exercise reasonable care when using a knife. In fact, because of the common knowledge of the danger, a warning would be superfluous.

Finally, we must ask whether it is possible to eliminate the danger without seriously impairing the usefulness of the product or making it unduly expensive. Even the best metallurgists today are unable to create a blade material that can distinguish between a chicken cutlet and a finger.

Upon analysis of these seven elements, it is fair to conclude that, on balance, the utility of the kitchen knife outweighs the risks, despite the significant hazard. That is, while the kitchen knife has dangers associated with its use, it does not contain unreasonable dangers, and therefore is reasonably safe.


Arisk/utility analysis for design safety
A comprehensive risk/utility analysis begins with acknowledging that the law has imposed upon the manufacturer the duty to reasonably foresee hazards arising from all aspects of product use. These include shipping, assembly, installation, testing, instructions, warnings, intended uses, misuses, inspection, maintenance, service, and disposal.

Hazards arise when people interact with the product while it is being used within an expected or reasonably foreseeable environment. The prospective risk/utility analysis must first consider the reasonably foreseeable environments in which the product will be used, the characteristics of the users, and how they will apply or misuse the product.

Reasonably foreseeable misuses are perhaps the most difficult consideration. The law has imposed this duty upon manufacturers because people are rarely as perfect as the products they use. We all have moments of inadvertence, emergency, or inattention which can lead us to use a product in a manner not intended.

For example, we all know the intended use of a screwdriver is to insert or remove screws, and the shank and handle must withstand the torques necessary to accomplish this task. But a screwdriver also is the most likely tool used for opening paint cans. Using it for this purpose could be characterized as a reasonably foreseeable misuse, and a careful manufacturer would design the screwdriver shank for a certain amount of bending as well as torsion.

The next step, postulating the hazards, should involve all departments having responsibilities for the product. Their objective is to reach a consensus on the hazards as well as to estimate, for each hazard, how probable the event is and how serious the harm would be. This approach permits ranking the hazards from most to least serious.

Next, delineate the means for reducing or eliminating the hazard. Ranking the hazards guides designers to where the greatest efforts must be made in modifying the product to reduce risk of injury.

Ideally, up to this point, cost should not be a consideration. If considered too early in the process, cost considerations tend to stifle creativity and restrict thinking globally about effective means to reduce harm. However, once the alternatives have been identified, the next step is to consider the effect on performance, utility, and cost. Finally, the decision must be made as to which of the alternatives, procedures, user communications, and so forth will be incorporated into the design of the product.

A critical component of this process is proper documentation. This is vital to compare actual product behavior and use with that projected during the design process. It also permits assessing the validity and comprehensiveness of the risk/utility analysis and the overall design process so that when the next model or re-design is contemplated, there is a comprehensive foundation from which to build.

Documenting the process also helps in demonstrating to a jury how carefully the company designed, instructed, and warned about its product, if it is ever alleged to be unreasonably dangerous and caused harm.

© 2010 Penton Media, Inc.