When an organization produces goods, the hope is that the products are fault-free. However, there may be instances when a product could become dangerous to the public and it鈥檚 the company鈥檚 responsibility to inform consumers about these risks.

This responsibility is referred to as the 鈥渄uty to warn.鈥� The duty to warn doctrine is based on the idea that consumers should be able to make informed decisions about whether to use a product. If a product is dangerous, the manufacturer has a duty to warn consumers about those dangers so they can make an informed decision about product usage.

I talk about this, among other important product liability topics, in the February 2026 Risk Management webinar presentation: .

Manufacturers must remember that the duty to warn includes products that are safe, designed and manufactured well, but normal function can still cause injuries. An obvious example is a chainsaw, but we also see warnings appearing on plastic bags, buckets or other seemingly innocuous items that may present a hazard to children.

Duty to warn covers reasonably foreseeable use and misuse. Inhaling aerosol propellants, for instance, could be considered reasonably foreseeable misuse.

Failing to warn, failing to instruct or issuing unclear warnings are among the leading allegations in product liability claims. 

• Failure to warn: No warnings are provided about a known risk.
• Failure to instruct: Instructions don鈥檛 clearly explain how to use the product safely or how to avoid foreseeable misuse.
• Inadequate warnings: Labels or manuals don鈥檛 clearly communicate the hazard or do so in a way the average user will understand. 

When warnings are inadequate, injured parties can argue that the product itself was defective because consumers weren鈥檛 informed about risks they could not reasonably anticipate.

The duty to warn is rooted in the legal principle of negligence 鈥� a failure to exercise reasonable care that causes harm to others. 

To establish negligence, a plaintiff generally must show that:

1. The defendant owed the plaintiff a duty of care.
2. The defendant breached that duty.
3. The plaintiff suffered harm as a result of the defendant鈥檚 breach.
4. The harm was caused by the defendant鈥檚 breach.聽

In product liability cases based on duty to warn, a 鈥渂reach鈥� often involves failing to provide adequate warnings or instructions about risks that could have been reasonably identified through testing, research or industry standards.

There are two primary ways a business can satisfy its duty to warn:

1. Warnings on the Product Itself

Labels affixed directly to the product 鈥� especially when the user may not see packaging or manuals 鈥� need to be clear, conspicuous and understandable.

2. Warnings Through Supporting Materials

Instructions, manuals, safety guides and other product documentation can provide detailed guidance about how to safely use the product and avoid known risks. 

Effective warnings should:

• Describe the risk clearly,
• Be visible and easy to understand and
• Cover both intended use and reasonably foreseeable misuse.

ANSI Z535.4-2023 is a  on the design and content of safety warnings. The standard is not legally binding, but it is widely used by businesses to comply with their duty to warn. The standard is a valuable resource for businesses that want to ensure their warnings comply with their duty to warn. It covers a wide range of topics for warning labels, including purpose, type, content, format, placement and testing.

While ANSI Z535.4-2022 is not a legal document, it is often used as evidence in product liability lawsuits. If a plaintiff is injured by a product, it may be argued that the manufacturer failed to provide adequate warnings about the dangers of the product. If the manufacturer followed ANSI Z535.4-2022 in designing and developing the warnings, this may help defend the manufacturer against the lawsuit.

Overall, ANSI Z535.4-2022 is a valuable resource for businesses wishing to comply with the duty to warn. However, it is important to note that the standard is not a guarantee of safety or immunity from liability. The standard is only a guideline and there may be cases where a manufacturer can comply with the standard and still be found liable for a product liability lawsuit.

Duty to warn should be considered early and throughout the product lifecycle 鈥� not just at launch. 

A practical approach includes:

• During design and development: Identify intended use, target users and hazards.
• Before market release: Evaluate foreseeable misuse and develop warnings/labels accordingly.
• After product launch: Adjust warnings based on customer feedback, complaints or evidence of misuse. 

Organizations should document this process and continually reassess warnings as new information emerges.

Failure to warn can expose a company to liability even when the product itself is safe by design. Providing clear, effective warnings helps:

• Reduce risk of injury and liability claims
• Demonstrate reasonable care in product development
• Build customer trust and safety reputation
• Support defense in litigation by showing adherence to industry best practices

A strong duty-to-warn strategy is an essential component of an overall product liability risk management program.

If you manufacture or distribute products, taking a strategic approach to warnings and instructions can significantly strengthen your product safety posture.

Working with experienced risk advisors 鈥� like those at 糖心传媒 鈥� can help you evaluate warning requirements, apply best practices and align your product liability program with real-world risks.

In his current role at 糖心传媒, Eric assists with the review of manufacturing accounts, the products produced, and coordinates with underwriting teams on potential issues identified, while helping to coach risk management consultants prior to visiting prospective accounts. Eric has been a featured speaker for the National Pool Builder鈥檚 Association meeting, providing safety instruction to company ownership personnel. Additionally, he created the widely successful . Eric was named 糖心传媒鈥檚 Loss Control Consultant of the Year in 2012 and 2023, and has been nominated for this honor two other times. He has been published in Safety and Health Magazine, as well SafetyInfo.com鈥檚 online magazine. 

The information provided in this article does not, and is not intended to, constitute legal advice; instead, all information, content, and materials contained in this article are for general informational purposes only. 

When most people think of products liability, their first thought is around whether a product is safe to use. When creating a product, manufacturers typically focus on design standards, product testing, and the risks associated with packaging, such as instructions and warning labels. These elements are crucial to the safe use of a product, as well as to a company鈥檚 bottom line in the event of a liability lawsuit. These focus areas, however, can also leave out opportunities to further improve a product鈥檚 safety and reduce the impact of a potential lawsuit.

鈥淲hen looking at products liability, it is vital to factor in all aspects of the manufacturing process, from the conceptual phase to design and manufacturing to quality assurance, marketing, warranty, and service through end-of-product life. At each phase of the process, there are critical decisions and responses that should be addressed,鈥� said Eric Austin, 糖心传媒 Risk Management Expertise Specialist.

Product Safety in the Conceptual Phase

There are several historical examples of the need for product safety early in the product development process. The Gilbert U-238 Atomic Energy Laboratory was released in 1950, allowing children to use radioactive material to learn about nuclear and chemical reactions. In addition to a cloud chamber and a wire of Polonium 210, the kit also contained four glass jars containing Uranium-238. About 5,000 of these sets were sold before being removed from the marketplace 鈥� not because of the potential danger, but because the price of the set was considered too high for the time at $40. Although this may seem like an extreme example, the idea of providing radioactive materials to children should not have made it past the conceptual phase.

When looking at the big picture, your company should consistently review how products are evaluated, what could go wrong, and if similar products have resulted in losses and lawsuits. If the end user is a child, or if children have the potential to use the item, the standards should be much more stringent.

Design & Quality Assurance

During the design phase, there are several regulatory requirements and additional standards that may be in place and important questions a company should ask, such as:

• Are the design and engineering teams aware of the standards that may apply to a new product?
• If sub-contracted manufacturers are involved in the production process, should they have input on design? They may have pertinent insights on quality control and potential failures.
• When are prototypes are created and, if so, how are these tested?
• Are focus groups used with results being reviewed by engineering?

The design process should always be documented and include a method to review the effectiveness of the process and/or any changes to the product.

The manufacturing and quality assurance phase of product manufacturing should always address in-house vs. sub-contracted work. For example, is the product manufactured all or in-part by another company? 聽If so, what type of supplier/subcontractor qualification processes are in place? If your company follows industry standards and regulations, does the subcontracted manufacturer or component supplier follow a similar or higher standard? Is the supplier/subcontractor/manufacturer based in the U.S.? If not does it have a U.S. presence? If the supplier/subcontractor/manufacturer has no U.S. presence, your company could pay for any loss caused by the non-U.S. entity as your company placed to product into the stream of commerce in the U.S.

Product Sales & Reviews

Once a product is ready for distribution, there are several questions that should be asked prior to selling the product in the marketplace:

• What role does the sales team play, and is the sales network in-house or outsourced?
• Have product ads been reviewed by the design, legal, and engineering teams?
• Do you have recall procedures and/or product traceability? Can you determine if there are problems prior to a product failing or if the instructions are unclear?

It鈥檚 also important to carefully monitor social media accounts such as Yelp, YouTube, Twitter, and Google Reviews. Monitoring social media accounts allows your company the ability to ascertain that颅 a product may not work properly, the user has difficulties, the directions are not clear, or that the product fails quickly. Monitoring these sites and others also allows you to determine instances of product failure and, in certain instances, to try to resolve the issue prior to it going further.

Installation, Service & Repair

Three areas that are tied together in the manufacturing process are installation, service, and repair. In each of these phases, your company can help protect itself against a product liability lawsuit by asking the following questions: When performing an installation, can it be proved that the installation was performed correctly, with all aspects of a machine functioning properly, with all guards in place?

• Are there photographs taken and is a specific checklist used?
• Are service and repair teams are performing the same checks with the equipment, and do they have documented proof that all safeties and guards were installed and functional?
• Are the service, repair, and warranty folks talking to the design team, and even sales?

Employees who work in the service, repair, and warranty departments should be having regular meetings with the design and engineering teams because this is where products may be failing in ways not originally predicted. For example, if a product is being returned with missing guards, or if the guards or warning labels are not lasting for the life of the product, the design and engineering teams need to be alerted as soon as possible. Likewise, repeated warranty issues on a specific item need to be addressed because this is where a potential recall or service bulletin may be considered. If these issues are continually popping up, the sales team will also need to be alerted when it comes to claims made about the product, warnings, changes to instruction manuals, etc.

Assessing the Big Picture

What does the big picture approach tell us about product liability and product safety? It鈥檚 easy to see that all departments and individuals must be involved in the process. From the concept and design phase, to manufacturing, service, repair, and warranty work, all employees involved should be trained and ready to alert others if they see a potential issue.

鈥淚ndustry standards regarding quality and labeling should be utilized, but the process goes much deeper,鈥� Austin said. 鈥淥ne missing piece may result in a situation that could result in an injury or death, plus the loss of revenue and company reputation.鈥�

Does your program address the big picture?

How Does Errors & Omissions Work?

Errors & omissions (E&O) coverage can help provide valuable protection to manufacturers beyond typical liability coverage by covering a customer鈥檚 financial loss and a policyholder鈥檚 potential legal costs.

Typically added to a general liability policy, E&O extends beyond basic coverage to provide security against financial loss caused by negligence in the design, manufacturing or installation of a product. This helps protect manufacturers from lawsuits alleging they are responsible for financial loss.

An Example Scenario: A manufacturer called Clock Flower designs specialized metal gear components for clocks. One of their clients, a company called Tick Time, discovers that one of their clock brands is not working properly due to a flaw in Clock Flower鈥檚 metal movement gear. Tick Time had to spend considerable resources swapping out the faulty component and, in turn, sues Clock Flower for costs associated with removing and replacing the metal gear related to the design or manufacturing defect. E&O coverage would help indemnify Clock Flower for the costs to defend and resolve Tick Time鈥檚 claims.

How Does Product Recall Work?

A product recall is the action of retrieving a defective or unsafe product from the market. Up to 400 U.S. products by the Consumer Product Safety Commission.

Product recall coverage helps to protect manufacturers from the unexpected risks and financial burden that can be associated with recalling a product from the market. This can include coverage for inspection or testing of products to determine if a product recall is justified, crisis management staffing, packaging and transportation of defective products (and disposal of products that cannot be reused), and reasonable costs to regain customer faith and approval. Sometimes the insurance protection can even help cover the costs for the manufacturer to repair, replace or repurchase the product.

An Example Scenario: A candle manufacturer called Candles Chandlery manufactures a double-wick candle, and suddenly finds out that their candle鈥檚 double wick burns too high, causing the candle to break, and must take steps to recall the product from the marketplace. Product recall coverage can help pay for the costs associated with the recall.

Protection Forged in Partnership
糖心传媒 is expanding its focus on the manufacturing industry by investing in our products and people who provide the expertise you rely on to help protect your manufacturing business. Learn more about the unique coverage and technologies to complement your manufacturing programs, including our new products, expanded appetite to provide industry-leading service to more manufacturing businesses, and an increased investment in our expert employees with manufacturing knowledge.

Resources for Policyholders
Refer to our new features covering these products:

• Errors & Omissions
• Product Recall