Expertise Specialist at Amerisure
The Lawsuit That “Shouldn’t” Happen
The product passed every relevant regulation. The lab reports were clean. The required certifications were all in place, and the launch review came back with no open compliance issues. Years later, a complaint arrives alleging the product has caused a serious injury. The first reaction inside the company is sheer disbelief. How can there be a Products Liability claim on a product that met every single regulation?
The answer is straightforward (if uncomfortable). Compliance is proof of a significant step having been taken, but it is not a shield against Products Liability claims. A compliant product can still be challenged on the grounds of poor design, inadequate warnings or being unsafe in reasonably foreseeable circumstances. Certification may well close a project door. It doesn’t close the safety question.
For manufacturers, effective Products Liability risk management begins with recognizing that distinction: meeting regulatory requirements is essential, but designing for real-world safety requires looking beyond them.
The Compliance Trap
Regulations set a minimum floor. They are the product of the tests, the assumptions and the technology that were available at the time they were written. They can’t possibly anticipate every design variation, every user group, every operating environment or every conceivable way in which the product might be misused.
A pass on a prescribed test answers a very specific question: did the product meet the requirement under the specified conditions? A Products Liability case asks a much wider question: was the product reasonably safe under reasonably foreseeable conditions of use? Teams that treat the first question as the final answer may well stop there, even as significant risks remain unaddressed.
“Compliance gives manufacturers an important foundation, but it shouldn’t be the final question in a product safety review,” said Eric Austin, Risk Management Expertise Specialist at Amerisure.
“The greater opportunity is to understand how a product will actually be used, where hazards could emerge and what practical steps can reduce those risks before they become injuries or claims.”
The Gap Between Compliance and Products Liability Risk
Start with the obvious uses and reasonably foreseeable misuse. How will people actually go about installing, using, cleaning, maintaining, modifying or circumventing the product? Don’t assume they’ll always follow the manual. Then consider what the company knew (or should have known) from testing, previous models, suppliers, customer experience, incidents and the general body of industry knowledge.
The next question is whether there were practical, safer designs available. Those options must be evaluated in terms of performance, reliability, cost and any new risks they would introduce. Warnings and instructions should clearly communicate remaining risks to users where appropriate. A warning can’t in itself replace a practical design improvement, and a perfectly accurate manual can still fail if the critical message is missing.
The company also needs to reconstruct its rationale years after the fact. A record that contains nothing but the final decision is not sufficient. You can’t really justify a good decision without the evidence and the trade-offs that went into it.
A Real-World Wake-Up Call
The Minnesota Supreme Court’s 1980 decision in Gryc v. Dayton-Hudson Corp. is a textbook example of how compliance with a statute can be very different from reasonable safety. Riegel Textile Corporation’s cotton flannelette for children’s pajamas was in compliance with the federal Flammable Fabrics Act and passed test CS 191-53 (the historical test applicable at the time; federal flammability requirements have since evolved). In December 1969, however, four-year-old Lee Ann Gryc reached over an electric stove to turn off a timer. The top of her pajamas came into contact with a burner and caught fire immediately. In a reconstruction presented at trial, the fabric burned from hem to neck in four to five seconds. She sustained severe second- and third-degree burns over 20% of her body and had permanent scarring.
At trial, Riegel focused on compliance. The company maintained that the fabric met federal standards, required no warning and that no commercially viable flame-retardant alternative existed. The plaintiffs presented a different picture, arguing that cotton flannelette was unreasonably dangerous for children’s sleepwear, that safer alternatives were available and that consumers had not received adequate warnings. Evidence described in the Minnesota Supreme Court’s opinion supported the plaintiffs’ position that meeting federal requirements did not necessarily establish reasonable product safety.
The case also exposed important limitations in the federal flammability test, CS 191-53. Evidence showed that the test was an unreliable indicator of how fabrics such as cotton flannelette would perform under real-world conditions. The court noted that even newspaper passed the prescribed test with a 48% margin of safety. Evidence also showed that the textile industry influenced the development of the test and that Riegel knew of its limitations. The jury awarded $750,000 in compensatory damages and $1 million in punitive damages — a combined $1.75 million. As documented in the official Minnesota State Register, the Minnesota Supreme Court upheld the awards, concluding that compliance with the applicable federal safety standard did not, by itself, preclude punitive damages.
Standards still matter. But passing a test designed for different materials and conditions doesn’t necessarily establish that the product is reasonably safe. The safer alternatives, the missing warnings and Riegel’s own knowledge that the test had understated the hazard all took the analysis well beyond the certificate. Compliance was the starting point of Riegel’s argument. It was not the end of the court’s review.
The Time-Lag Problem
Regulations are inherently reactive. Rulemaking takes time, while technology, field conditions and expectations continue to evolve. An incident, a new material, a software feature, a change in behavior or the introduction of a better safeguard may expose a hazard before a standard has time to catch up.
A compliant product can therefore be subject to very different scrutiny years later. Field experience might reveal an untested failure mode, a competitor might have introduced a practical mitigation, or internal data might show that “rare misuse” is actually quite common. The way the company responds to that new knowledge is as important as the original certification file.
Product recalls offer another reminder that safety considerations continue after products enter the market. The CPSC’s recall database tracks hazards ranging from fires and burns to falls, entrapment and equipment malfunctions, illustrating the variety of risks that can require action after distribution.
Shift the Internal Question
The most valuable cultural shift is from “Can we certify this product?” to “Can we defend this design as being reasonably safe?” The second question builds on compliance rather than replacing it. It forces engineering, product development, legal and leadership teams to confront three issues:
- Does the design actually address the real risk?
- Are the residual risks acceptable?
- Can the team explain its rationale under rigorous, informed scrutiny?
This shift turns product safety from a final approval checkpoint into an ongoing responsibility, and one that connects design decisions, field experience and the people accountable for both.
Practical Steps for a More Defensible Product
Strong product safety practices are built through decisions that can be tested, explained and revisited. For manufacturers, that means taking several deliberate steps:
- Go Beyond the Regulation. Start with the hazard and the exposed users. Treat the standards as inputs rather than as the outer limit of your inquiry. Document a full hazard analysis. The Design Failure Mode and Effects Analysis (DFMEA) should link the hazards, the risk estimates, the controls, the verification and the acceptance of the residual risk. Don’t let it become a scoring exercise.
- Keep a Record of Design Options. Record the safer options, the test results, the trade-offs and why each option was accepted, changed or rejected. Do it at the time of the decision, not after an incident.
- Validate to the Risk, Not Just the Procedure. Include scenarios that reflect misuse, environmental extremes, variation, aging, maintenance errors and conditions that could defeat the safeguards.
- Treat Field Data as a Live Signal. Warranty claims, near misses, service reports, returns and incidents should feed into a process that can revisit earlier assumptions before a small event becomes a significant loss.
- Require Cross-Functional Sign-Off. Engineering, Legal, Compliance, Quality, Product Leadership and the accountable executives all need to understand the safety trade-offs and their respective responsibilities.
- Build the Record for Future Readers. Capture the inputs, the assumptions, the alternatives considered, the tests run, the dissenting views, the approvals and the triggers for the decision. A future team or a jury should be able to see why the decision made sense at the time.
Legacy Products Are Not Off the Hook
A product doesn’t become a closed file when the launch team goes away. New incidents, new applications, new suppliers, changing service experience and improved safeguards can all lead to old issues being revisited.
Manufacturers therefore need a practical process for the ongoing monitoring of legacy products, and they need to be in a position to decide whether a warning, a service action, a design change, a customer notice or some other action is required. Relying solely on the fact that a product complied at the time of release can leave manufacturers exposed to emerging risks. When credible new evidence emerges, the company faces a new decision—one that may attract greater scrutiny than the original design itself.
“A product’s safety story doesn’t end when it leaves the manufacturing facility,” Austin said.
“Warranty claims, service reports and customer feedback can reveal risks that weren’t apparent during development. Manufacturers that pay attention to those signals and act on what they learn are better positioned to protect customers and make informed decisions about their products.”
Compliance Is the Starting Line
Product integrity is not a compliance box to tick. It’s a discipline rooted in clear, traceable judgment. You have to be honest about hazards. You have to question assumptions, consider safer alternatives, test against real-world risks, listen to the field and document the reasoning that goes into making a difficult decision.
Manufacturers that build this discipline are in a far better position to avoid harm, respond to change and explain their decisions when challenged. They protect their customers, they strengthen their engineering and they protect the very trust that their business is founded upon.
Building a defensible product starts long before a claim and continues well beyond certification. Learn more about strengthening product safety practices and managing manufacturing risks through Amerisure’s Risk Management resources, or connect with your Amerisure Risk Management Consultant.
