What Is an Unavoidably Unsafe Product?
If a medication, car part, or other consumer product has injured you or a loved one, you may wonder what happens when a product is carefully designed, manufactured, and marketed, but is still dangerous. Is the manufacturer, distributor, or seller of the product responsible for the injury? The answer depends, in part, on whether the product falls within specific guidelines to qualify as an "unavoidably unsafe product." If a product is found to be unavoidably unsafe then it’s not a defective product, even if it causes injury.
Is the Product Defective?
A product can be defective in 3 main ways:
1. If a product is marketed with inadequate instructions or warnings as to foreseeable risks, it has a marketing defect.
2. If it's manufactured with a flaw, but the design and marketing are fine, it’s called a manufacturing defect.
3. If a product is designed in a way that injury could foreseeably result, and if the risk of injury could have been reduced by an alternative design, then a product is said to have a design defect.
Usually, if a product is defective in how it was marketed, manufactured, or designed, and someone is injured by the defect, then the manufacturer, distributor, or seller of the product are responsible for the consequences of the defect. However, the courts created an exception for products considered "unavoidably unsafe."
Is the Product Unavoidably Unsafe?
An unavoidably unsafe product isn’t necessarily by its nature dangerous. Rather, it’s a product that is incapable of being made safe for its intended and ordinary use. Courts generally look at 4 criteria to determine if a product is unavoidably unsafe: how the product was prepared, how it was marketed, the utility of the product compared to its risk, and whether there are any alternatives available.
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. For drugs or vaccines, the product can’t be adulterated and it must work as intended. If it’s not prepared correctly or is ineffective, then it can’t fall under this exception. While a product can’t be adulterated and qualify for the exception, it can contain impurities in the ingredients. For example, blood tainted with impurities like hepatitis or HIV might qualify for the exception.
The product must be appropriately marketed. If the product directions are faulty or it’s sold with inadequate warnings, it may not be unavoidably unsafe. Thus, if a drug is marketed with no indication as to how or who should take it, then it may not fall under this exception. Similarly, if the drug is marketed with no warnings as to potential adverse reactions, it may not be considered unavoidably unsafe.
Utility vs. Risk
The utility or usefulness of the product must outweigh its risk of danger. For example, if a drug cures a mild case of hiccups, but causes death in half the people who use it, it wouldn’t be unavoidably unsafe. A product doesn’t need to save lives to be considered useful. Products ranging from birth control to beauty products have been found to be sufficiently useful to warrant the risk associated with their use.
Lastly, there must not be any other way to fully achieve the intended purpose of the product. If there’s 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 if there’s an alternative, courts have considered the risk avoided by the alternative and the cost, benefits, and relative safety of the alternative. For the hiccup cure, a bottled water would be a safe alternative product making the hiccup cure not unavoidably unsafe.
Types of Unavoidably Unsafe Products
The most widely recognized category of unavoidably unsafe products is prescription drugs. Some courts hold that all medications automatically qualify as unavoidably unsafe on the theory that public policy favors the development of beneficial drugs even if their introduction poses some risk. Other courts weigh the usefulness of the drug against its risk of harm in the same way they would for any other product.
Some courts also find medical devices, vaccines, and blood products are 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 life and public health the product is and whether the FDA looked at it to determine its risk vs utility.
Other products that have generally qualified as unavoidably unsafe include guns, cleaning compounds like commercial dry-cleaning solvent, industrial-strength bathroom cleaners, and acetone, as well as benzene and cosmetics like hair perms, bleach, and dye. Conversely, natural gas stoves, cars, folding chairs, and fire extinguishers haven’t been found to be unavoidably unsafe.