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What Is an Unavoidably Unsafe Product?

If a prescription drug, vehicle component, or other consumer product has caused an injury to you or a loved one, you may be wondering what happens when a product is carefully designed, manufactured and marketed, but is dangerous nonetheless. Must a manufacturer, distributor, or seller of the product bear responsibility? The answer depends in part on whether the product falls within very specific guidelines to qualify as an "unavoidably unsafe product." If a product is found to be unavoidably unsafe then it is not a defective product, even though it might cause injury.

Is the Product Defective?

As a general rule, the question central to any product liability case is whether the product is in fact defective. A product can be defective in a number of ways. If a product is marketed with inadequate instructions or warnings as to foreseeable risks, it has a marketing defect. If a product is manufactured with a flaw, but the design and marketing of the product are fine, it is called a manufacturing defect. If a product is designed in such a way that it is foreseeable that injury could result, and if the risk of injury could have been reduced by an alternative design, then a product is said to be defective in its design. When looking at alternative designs, courts will look at the costs associated with the alternative designs. Courts also look at whether the proposed alternative would have reduced the foreseeable risks of harm associated with the product, and whether the failure to use the alternative design made the product unreasonably unsafe at the time it was manufactured. Usually, if a product is defective in the way that it is marketed, manufactured, or designed, and someone is injured as a result of that defect, then the manufacturer, distributor and/or seller of the product are liable, or responsible for consequences of the defect. The courts have however carved out an exception for products considered "unavoidably unsafe."

Is the Product Unavoidably Unsafe?

An unavoidably unsafe product is not necessarily a product that is by its nature dangerous. Rather, it is a product that is incapable of being made safe for its intended and ordinary use. What makes a product unavoidably unsafe as opposed to downright dangerous? Courts generally look at four criteria in making the determination: the manner in which the product was prepared, the manner in which it was marketed, the utility of the product compared to the risk it poses and whether there are any alternatives to the product available.

Preparation

If a mistake is made while manufacturing the product and that mistake makes the product ineffective or dangerous, the product may not be unavoidably unsafe. In the case of a prescription drug or vaccine, the product must not be adulterated and it must actually work as intended. If it is not prepared correctly or is ineffective, then it can not fall under the unavoidably unsafe exception. While a product cannot be adulterated and qualify for the exception, it can contain impurities in the ingredients. So, for example, blood tainted with impurities such as hepatitis or HIV might qualify for the exception.

Marketing

The second requirement of the unavoidably unsafe exception is that the product be appropriately marketed. If the directions accompanying the product are faulty, or if the product is sold with inadequate warnings, it may not be unavoidably unsafe. Thus, if a prescription drug is marketed with no indication as to how it should be taken, or by whom it should be taken, it may not come within the unavoidably unsafe exception. Similarly, if the drug is marketed with no warnings as to potential adverse reactions or contraindications, it may not be considered unavoidably unsafe.

Utility vs. Risk

The third requirement is that the utility or usefulness of the product must outweigh its risk of danger. So, for example, if a drug cures a mild case of hiccups but causes death in half the people who use it, it may not qualify as unavoidably unsafe. It is worth noting that a product need not save lives to be considered useful. Products ranging from birth control medications to beauty products have been found to be sufficiently useful to warrant the risk associated with their use.

Available Alternatives

The fourth requirement is that there must not be any other way to fully achieve the intended purpose of the product. If there is an alternative product that would be as effective in accomplishing the purpose of the product then the product may not be unavoidably unsafe. In determining whether there was an alternative, courts have considered the risk avoided by the alternative, the financial cost of the alternative, the benefits of the alternative, and the relative safety of the alternative. In the case of the hiccup cure, a bottle of water would be a safe alternative product making the hiccup cure unlikely to qualify as an unavoidably unsafe product.

Types of Unavoidably Unsafe Products

What types of products generally qualify as unavoidably unsafe? The most widely recognized category of products is probably prescription drugs. Indeed, some courts hold that all prescription drugs automatically qualify as unavoidably unsafe on the theory that public policy favors the development of beneficial drugs even though some risks might accompany their introduction. Other courts weigh the usefulness of the drug against its risk of harm in the same manner as they would for any other product. The same reasoning that leads many courts to conclude that prescription drugs are unavoidably unsafe leads courts to conclude that medical devices, vaccines, and blood products are also unavoidable unsafe. When deciding whether these products are unavoidably unsafe the court may look at the type and quality of research done on the drug or device. Courts also look at how necessary to human survival and public health the medical product is, and whether the FDA looked at the medical product to determine its risk vs. its utility.

Although medical products make up the majority of products found to be unavoidably unsafe, the unavoidably unsafe exception is not limited to medical products. Products that have generally qualified as unavoidably unsafe include cleaning compounds such as commercial dry-cleaning solvent, industrial strength bathroom cleaning products, and acetone, as well as cosmetics such as permanent wave solutions, hair bleach and hair dye. Products such as benzene and firearms have also qualified. On the other hand, natural gas stoves, automobiles, folding chairs and fire extinguishers have not been found to be unavoidably unsafe.

Next Steps
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