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’s the company’s responsibility to inform consumers about these risks.

This responsibility is referred to as the “duty to warn.” 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. 

What Is Included in Duty to Warn?

Manufacturers in particular 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. 

The Leading product liability allegations include failure to warn, failure to instruct, and inadequate warnings. Failure to instruct means that the operations for a product were not adequate for safe use, or, ignored foreseeable misuse. Instructions should include warnings about removal of guards, or those who should not use a particular product. Children, for example, should not use power tools or different types of cooking appliances.

An inadequate warning may not be clear to the user or may not sufficiently warn the user of what the hazard is. 

Principle of Negligence

A businesses’ duty to warn is based on the legal principle of negligence, or a failure to use reasonable care that results in harm to another person.

What is considered negligence? To establish negligence, a plaintiff must prove four elements:

1. The defendant owed the plaintiff a duty of care.
2. The defendant breached that duty by failing to use reasonable care.
3. The plaintiff suffered harm as a result of the defendant’s breach.
4. The harm was caused by the defendant’s breach.

Fulfilling Duty to Warn

In the context of product liability, the duty to warn arises when a product is considered unreasonably dangerous, meaning it is more dangerous than a reasonably prudent person would expect it to be.

There are two main ways a business can fulfill its duty to warn:

1. By providing adequate warnings on the product itself.
2. By providing adequate warnings in other ways, such as through product literature or safety instructions.

These warnings must be clear, conspicuous, and adequate enough to inform consumers about the dangers associated with the product, or misuse of the product.

Warning Standards & Guidance

ANSI Z535.4-2022 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.

How Standards Apply to Products Liability Lawsuits

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. 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.

Where to Start

During the design phase of a product, a manufacturer should understand the intended use, target audience or those that may use the product, and potential hazards of a product. Those in engineering, design, manufacturing, legal, and risk management should be tasked with assembling all of the relevant data on a product. 

Step two would be identifying all possible ways a product can be used/misused. Looking at similar products in the marketplace can be of assistance, plus any lawsuits or even simple complaints on existing similar products. An evaluation of these factors should be made, with warnings being made to not only comply with the standards listed above, but also from what was learned in the design phase analysis.

Finally, once a product is in the marketplace, warnings should be adjusted according to complaints on instructions, product failures, or known examples of misuse. If a new label is determined to be necessary to comply with the standards on subsequent products, then it may be necessary to send an alert out to those who have already purchased the product with the new label or instruction update, along with proper placement (if it is a label being sent). A business must prove that they did everything a responsible business could do to protect the consumer and public. 

Learn More                     

Learn more about product liability and ANSI standards:

• Product Liability and the Big Picture
• Building a Cross-Functional Products Liability Program

And stay tuned for the next article in this series: Products Liability & Social Media

About the Author

In his current role at 91şÚÁĎÍř, 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’s Association meeting, providing safety instruction to company ownership personnel. Additionally, he created the widely successful . Eric was named 91şÚÁĎÍř’s Loss Control Consultant of the Year in 2012, and has been nominated for this honor two other times. He has been published in Safety and Health Magazine, as well SafetyInfo.com’s 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’s bottom line in the event of a liability lawsuit. These focus areas, however, can also leave out opportunities to further improve a product’s safety and reduce the impact of a potential lawsuit.

“When 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,” said Eric Austin, 91şÚÁĎÍř 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 – 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?  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’s 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 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’s 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.

“Industry standards regarding quality and labeling should be utilized, but the process goes much deeper,” Austin said. “One missing piece may result in a situation that could result in an injury or death, plus the loss of revenue and company reputation.”

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’s financial loss and a policyholder’s 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’s 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’s 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’s 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
91şÚÁĎÍř 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