Whether a company manufactures chemicals, processes industrial materials, or operates facilities where workers may encounter hazardous substances, the duty to warn is one of the most important legal and regulatory requirements. Not only does this duty allow consumers to make informed decisions, but it also protects a company from liability. By understanding the circumstances under which failure to warn claims can arise, companies will be better positioned to ensure compliance, mitigate risk, and safeguard both their reputation and bottom line.

What is a Failure to Warn Claim?

One of the most common allegations in toxic tort lawsuits is “failure to warn.” This is a type of product liability claim in which the plaintiff asserts their harm resulted from a marketing defect, rather than a flaw with the product itself. In these cases, the plaintiff relies on the argument that the defendant’s failure to properly communicate the risks of the product makes it unreasonably dangerous.

To prevail in a failure to warn claim, a plaintiff must be able to establish the following elements:

• The product or environment contained a dangerous substance
• The business knew, or should have known, about the risk
• The injury suffered could have been prevented with reasonable warning
• The lack of warning was the direct cause of the injury

Common defenses available to a defending company can include the obviousness of the risk, product misuse, and regulatory compliance. A company may also rely on the “sophisticated user doctrine.” This defense allows a manufacturer to avoid liability for failure to warn in situations where the user had the necessary expertise and knowledge to understand the hazards associated with the product.

What Situations Trigger Liability for Failure to Warn Claims?

Understanding the scenarios that can lead to failure-to-warn claims allows companies to more effectively assess risk and strengthen their compliance practices. Common situations that may trigger such claims include:

• Failure to communicate known (or knowable risks): The primary allegation raised in a failure to warn claim is that the company was aware, or should have been aware, of a potential hazard and failed to communicate it to the public.
• Insufficient or vague warnings: Even if the company included a warning on the product, a plaintiff may argue it was not detailed or specific enough to describe the harm or how it could occur.
• Failure to warn about reasonably foreseeable misuse: Although manufacturers are not required to warn about every potential misuse of a product, they are expected to warn against misuse that is predictable or reasonably foreseeable. In such cases, companies should consider whether additional warnings are appropriate.
• Failure to update warnings: Companies have an ongoing duty to update warnings when new information becomes available or regulatory requirements change.
• Inadequate warnings: A warning must be designed so that it can reasonably be expected to catch the attention of the consumer, and be comprehensible to provide a fair indication of the risks associated with the product.

Strong defenses in failure-to-warn cases often hinge on evidence of clear and consistent warnings, adherence to industry standards and regulations, and consideration of evolving scientific research. Depending on the plaintiff’s allegations, companies may also assert unforeseeable misuse, challenge causation, or argue that the existing warning was adequate. Furthermore, even a potentially valid claim can be barred if the statute of limitations or the statute of repose has expired.

How Can a Business Reduce Risk?

Many of the risks that give rise to failure to warn claims can be mitigated through proactive planning and implementation of best practices. While these types of claims depend on what the defendant knew or should have known about the product, companies should demonstrate ongoing awareness of new scientific studies — and create a structured process for monitoring developments. They should also prioritize periodic reviews of their labeling practices to ensure compliance with current industry standards and consumer expectations.

Compliance with industry norms and governmental regulations can help support the adequacy of a warning and provide companies with a framework for a solid defense. However, if feasible, companies should exceed the minimum regulatory baselines, especially if competitors have adopted similar practices. Doing so can help reduce the risk of legal exposure.

Warning development should start early and be communicated across departments. The use of clear, direct language in warnings that is consistent with marketing messaging creates stronger protection for companies. The meticulous documentation of a company’s research evaluations, coordinated communication, employee training, and regular review are not only best practices, but will also prove vital to building a strong defense in the event of litigation.

Contact an Experienced Toxic Tort Attorney

If your company is facing a failure to warn claim in connection with a toxic tort lawsuit, it is critical to retain experienced counsel to protect your interests. Taking a client-centered approach in every case, Cosmich is well-positioned to assist clients navigating the nuances of toxic tort lawsuits. With coast-to-coast offices, we are equipped to handle complex litigation across multiple jurisdictions. Contact us to schedule a consultation.