A warning label lawsuit is a lawsuit brought by a consumer of a product. Consumer products include food, drink, drugs, electronic devices, and mechanical devices. Federal law requires product suppliers and manufacturers to provide adequate warning of the dangers the product may pose. 

Warnings are in the form of a label that describes the dangers. Warning labels ensure consumers are aware of dangers a product may pose. A consumer injured by a product that was not properly labeled, may sue the product manufacturer or supplier for their injuries.

When Must a Product Contain a Warning Label?

Under federal law, if a product poses a danger that is not apparent or obvious to a consumer, the manufacturer of the product must place a warning label on the product. The label must warn of the danger. The law does not require warning labels for every hypothetical danger the product poses. 

For example, when the danger posed by a product is obvious (such as the obvious danger posed by use of a firearm), the law does not impose a duty to warn. The law requires a duty to provide warning against dangers that an ordinary user could not anticipate. A failure to warn when required to is  a design defect, or flaw in how a product was designed. 

What Kind of Warning is Adequate?

Generally, the manufacturer’s duty to warn arises when:

  • The product is dangerous;
  • The manufacturer knows or should know of the danger; 
  • The danger exists when the product is used in an expected manner; and
  • The danger is not one that is obvious to the user.

The manufacturer must provide a warning that is adequate. The manufacturer must provide a warning that adequately instructs a consumer on dangers posed by typical product uses. The manufacturer must also provide adequate instructions on safe product use. 

When Can the Manufacturer be Liable?

If a manufacturer or supplier breaches the duty to warn by not providing an adequate label, a consumer may sue. To prevail, the consumer must show the failure to warn proximately (legally) caused injury resulting in damages (losses that can be measured in terms of money). 

Under the law, a consumer may sue for inadequate warning when:

  • There are expected risks of harm posed by a use of a product;
  • The risks could have been lessened by giving the user adequate warning;
  • The failure to give these warnings rendered the product unsafe; and
  • A consumer sustained an injury on account of the failure to adequately warn.

Manufacturers have no duty to warn against uses that are unanticipated. For example, a manufacturer must provide adequate warnings on anticipated dangers of using a lawnmower. The manufacturer need not warn with respect to an unanticipated use. An unanticipated use is, for example, the use of a lawnmower as a weapon.

Who Must Warn?

The manufacturer of a product can be liable for failure to provide adequate warning. A supplier or distributor can also be liable. A supplier or distributor can be 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. Being in the “chain of sale” means the supplier or distributor transferred or sold the product, to make it available for consumer purchase.

Who Must be Warned?

Manufacturers, distributors, and suppliers need not provide warning to everyone. A distributor or manufacturer must warn those people whom it can anticipate are likely to use the product. The distributor must also warn those people whom it can anticipate are likely to be exposed to the danger of a product (such as family members who can access a product). 

What if the Product is Food, Drink, or a Drug?

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 regulates safety by requiring labels containing specific information. This information must describe what chemicals and other ingredients a food, drink, or drug product contains. 

Under federal law, a manufacturer of food, drug, or drink, may not state certain information with respect to the product. If the product claims to offer a health benefit, such as, “this product improves your concentration,” or “this product enhances your memory,” the product must include a disclaimer. 

The disclaimer must state, with respect to the alleged benefit, “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?

If you believe you sustained an injury from use of a product that lacked sufficient or appropriate warning labels, you should contact a defective products attorney. An experienced lawyer near you can evaluate your case, advise you of your rights and options, and represent you in court.