Failure To Warn: Product Liability For Label Defects (2026)

What Is Failure to Warn in Product Liability?

Product liability law determines when manufacturers must compensate consumers for injuries caused by their defective products. Defects fall into three categories. Design defects are inherent in the product, rendering it unsafe for its purpose. Manufacturing defects arise when products deviate from their design specifications.

Warning defects occur when the instructions and warnings provided with products expose users to injury or death. Specifically, a defective warning will fail to warn a reasonable consumer about the product’s proper uses and foreseeable risks.

Key Elements Required to Prove Failure to Warn

Product liability claims can assert several legal theories for holding manufacturers responsible for harm caused by their products, including the following:

• Strict liability tort
• Negligent tort
• Breach of warranty

Negligence requires proof that the manufacturer failed to exercise reasonable care in producing and selling its products. In “failure to warn” cases, you and your attorney will likely need proof that the manufacturer failed to warn users of a reasonable risk that it knew or should have known about.

Breach of warranty happens when a product cannot be used for its intended purpose because it is unreasonably dangerous. Deficient instructions can establish a warranty breach if they lack the information needed to use the product safely. The obstacle in many breach of warranty cases is that it is usually only available to the product purchaser.

The strongest claim is strict liability. Strict liability is powerful because the manufacturer can be held liable regardless of any of the following:

• It did not intend to release a defective product
• It did not know the product was defective
• It took reasonable measures to prevent the defect
• The user did not purchase the product

Instead, the manufacturer may be held liable simply by proving that the product was defective and the defect caused the victim’s disease or injury. When alleging a failure to warn, this usually means that the manufacturer’s instructions and warning labels insufficiently explained how to use the product safely.

Types of Products and Industries Involved in Failure to Warn Cases

Nearly any product can be the subject of product liability for a failure to warn. However, the following industries and products have faced recent litigation over a lack of warnings or instructions:

Pesticides

Pesticides are chemicals that often have side effects. For example, Roundup herbicide is used to kill weeds. Users who have developed non-Hodgkin lymphoma have filed Roundup cancer lawsuits arguing that the active ingredient, glyphosate, caused their illnesses.

These lawsuits allege, among other claims, that Roundup’s warnings did not explain that glyphosate could cause cancer despite the World Health Organization classifying it as a likely carcinogen. Moreover, the labels did not explain that users should wear personal protective equipment (PPE), such as respirators, when mixing and applying it.

Pharmaceutical Products

Over-the-counter and prescription medications are often the subject of lawsuits that allege a failure to warn.

Lawsuits against the manufacturer of Depo Provera, for example, allege that the company failed to warn users of Depo Provera side effects. As a result, these patients could not give informed consent because they lacked critical information about the risks of osteoporosis and brain tumors.

Other Chemical Products

A failure to warn is often alleged in cases against chemical products. They can cause long-term diseases, such as cancer and autoimmune disorders. In AFFF cases, for example, plaintiffs often use scientific evidence on AFFF and cancer to prove that fire-fighting foam manufacturers knew about the risks but failed to describe them on product labels.

Warning Label Requirements and Adequacy Standards

In most states, manufacturers must provide warning labels and instructions that fulfill the following requirements:

• Describe how to use the product safely
• Warn against foreseeable errors and misuses

These warnings must be understandable to the anticipated user. Thus, instructions for doctors might use more technical terms than those for ordinary consumers.

Common Defenses Against Failure to Warn Claims

Under strict liability, manufacturers tend to have very few defenses. However, they can assert the following:

No Causation

The manufacturer can claim that the product did not cause the victim’s injury or disease.

Adequate Warnings

Manufacturers can argue that the warnings were adequate because they gave enough information for users to protect themselves. Alternatively or additionally, the manufacturer could claim that improved warnings or instructions would not have prevented the harm.

Product Misuse

If the user misused the product, the manufacturer can argue that it is not responsible for the accident. If the misuse was unforeseeable, the manufacturer can allege that there was nothing it could have added to the warnings to prevent the injury.

Manufacturer Knowledge and Ongoing Duty to Warn

As the manufacturer gains knowledge about product risks, it may have a duty to perform the following:

• Update its labels and instruction sheets
• Issue a public announcement with new warnings
• Recall its products

When a manufacturer fails to reasonably update users about product risks, it may face lawsuits.

Damages and Compensation Available in Failure to Warn Cases

Victims may be able to seek compensation for economic and non-economic losses. Economic damages can be awarded for medical costs, lost wages and other expenses. Non-economic damages are granted for pain, suffering and other impacts on the victim’s quality of life.

Get Legal Help for Your Failure to Warn Case

ConsumerShield helps people injured by defective products understand their rights and find a lawyer. Contact us for a free case review.