Under federal law, if a product poses a danger that is not apparent to consumers, the manufacturer is required to place a warning label on the product to advise the public of the danger. The law does not require warning labels for every hypothetical danger the product poses; rather, a warning label is required for known risks. For example, when the danger posed by a product is obvious (e.g., firearms are inherently hazardous), the law does not impose a duty to warn.
The law says that manufacturers have the duty to provide warnings against dangers that an ordinary user could not anticipate. Warnings must be in the form of a label that describes the danger(s).
A warning label lawsuit is a civil litigation brought by a consumer of a product who was injured because of the lack of a warning label. Warning labels are designed to ensure that consumers are aware of the dangers a product may pose. A consumer injured by a poorly labeled product may sue the manufacturer, distributor, or supplier for their injuries. Failure to apply a warning label where needed gives rise to litigation based on the fact that there is a design defect in the product (the defect being that the label is not present).
When Does a Manufacturer Have a Duty to Warn?
Generally, the manufacturer’s duty to warn arises when:
- The product is in some way dangerous;
- The manufacturer knows or should be aware of the danger;
- The danger arises when the product is used in an expected manner;
- The danger is not obvious to the user.
The manufacturer must provide a warning that adequately instructs consumers of the dangers posed by the typical use of the product. Unfortunately, merely posting a warning of the danger posed by a product may not be enough. A manufacturer may still be liable if the warning provided is not deemed legally “adequate.” In addition, the manufacturer must also provide adequate instructions on safe product use.
There are the three types of warning label defects:
- Failure to warn: no warning at all is given;
- Failure to give a warning that is adequate: there is a warning, but it is not sufficient for a consumer to avoid the foreseeable risks of harm posed by the product, and the inadequacy of the warning makes the product unreasonably unsafe;
- Failure to adequately instruct: providing a warning of dangers does not fulfill the duty of manufacturers or sellers. They must provide instructions on the safe use or operation of a product as well. Instructions must allow a user to operate a product correctly.
When Can the Manufacturer Be Liable?
Negligence means failure to act with reasonable care. If a manufacturer breaches the duty to warn by not providing an adequate label, a consumer may sue under a theory of negligence. The elements that must be proved in a negligence action are:
- The defendant must have owed a duty to the injured victim. If the product is dangerous such that federal law requires a warning label, then the element of duty is proven – by law, the defendant owed the plaintiff the duty to post a warning label.
- The defendant must have breached the duty (e.g., the defendant failed to apply a warning label).
- The defendant’s conduct was the “actual” and the “proximate” cause of the injury. To analyze whether the defendant’s act or failure to act was the “actual” cause of the harm to the plaintiff, the court will usually apply the “but for” test – “but for” the defendant’s act (or failure to act), would the injury have occurred? “Proximate cause” means that the injury to the plaintiff was foreseeable – the defendant could have or should have predicted that their behavior could lead to the type of injury the plaintiff suffered.
- Once the other three elements have been met, the plaintiff will then need to prove that there was some damage resulting from the failure to attach a label. In other words, there has to be some sort of harm that occurred.
Manufacturers have no duty to warn against unanticipated uses. For example, while the lawnmower manufacturer must provide adequate warnings about the potential dangers of using the lawnmower to cut the grass, a manufacturer need not warn about what might happen if the lawnmower were used as a weapon.
Who Must Warn?
First and most obviously, the manufacturer of a product can be held liable for failure to provide adequate warning.
A supplier or distributor can also be found liable if the supplier or distributor was in the “chain of sale.” Being in the “chain of sale” means the supplier or distributor was an entity to which the product was transferred or sold by the manufacturer. Then the supplier or distributor transferred or sold the product to the consumer.
Who Must be Warned?
Manufacturers, distributors, and suppliers need not provide warning to everyone, but instead to those people it can anticipate are likely to use the product. The distributor must also warn people whom it can anticipate are likely to be exposed to a product’s danger (such as family members who can access the product).
What About Labels for Food, Drink, and Drug Products?
The Federal Food and Drug Administration (FDA), an agency of the federal Department of Health and Human Services, regulates food, drink, and drug safety. The FDA does so by requiring that all food, drink, and drug labels describe thoroughly and in detail what chemicals and other ingredients the product contains.
A food label violation is dangerous because food products have the potential to reach large sectors of the consumer population. If a food product is improperly labeled or dangerous, many individuals may suffer injuries such as food poisoning or food toxicity. These types of injuries may even result in a class action lawsuit, which is where one suit is filed on behalf of multiple parties who have been injured in the same way by the same product.
It is critical for manufacturers, distributors, and sellers to try to avoid a class action lawsuit. Their very purpose is to make it easier for many more people to sue the defendant, and since there are so many plaintiffs the monetary damage award can be huge.
Examples of food, drink, or drug labeling violations include:
- The labeling is difficult or impossible for the consumer to read;
- Failure to warn of risks that may be associated with the product;
- Misinformation regarding the standard or grade of quality of a product, such as labeling it “Grade AA” when it is an inferior grade;
- Incorrect expiration dates;
- False information regarding the nutritional content.
In addition to rules concerning what a food, drink, or drug label must contain, under federal law, there are certain things a manufacturer of food, drug, or drink may not state with regard to the product. An exception can be made if substantial scientific research is done to prove the validity of the claim.
If a product claims to offer a health benefit, such as, “This product improves your concentration” or “This product cures arthritic pain,” the product must include a labeled disclaimer. The disclaimer must state, “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Do I Need the Help of a Lawyer for a Warning Label Claim?
Labeling issues involve complex laws and legal analysis. If you believe you sustained an injury from the use of a product that lacked sufficient or appropriate warning labels, you should contact a defective products attorney. An experienced lawyer near you can review your situation, advise you of your rights and options, and represent you in court. Your attorney will assist you in obtaining a monetary damages award to compensate you for any injury or loss you have suffered.
Similarly, if you are manufacturing, distributing, or selling a potentially dangerous product to consumers, you should protect yourself by meeting with a products attorney to make sure your labels meet all requirements.
