Product liability suits and regulatory product defect enforcement actions associated with consumer foreseeable – and unforeseeable – misuse have become the norm. Consumer product companies can mitigate these risks by focusing on use-related hazards and user-centered designs in an effort to reduce injuries and improve the usability of products. But the real question is how far to go with these efforts — at what cost and for what incremental benefit.
On March 15, 2018, the Consumer Product Safety Commission published Draft Guidance on the Application of Human Factors to Consumer Products for industry comment by May 14, 2018. The draft guidance was developed in conjunction with Health Canada’s Consumer Product Safety Directorate. CPSC and Health Canada aim to increase product safety by explaining to product designers and manufacturers how to incorporate human factors into the design process.
The draft guidance describes the product design process and provides guidance on human factors considerations at each stage and then summarized in the graphic depictions collected at the end of this post. Because the guidance is not an enforceable rule, no cost benefit analysis accompanies the myriad of product design recommendations proposed.
While manufacturers and designers already include some human factors elements in their design processes, attempting to incorporate all or even enough of the Consumer Product Safety Commission’s draft guidance recommendations to meet these regulatory expectations will be costly. It could require, among other things, hiring a human factors specialist; implementing foreseeable-use analysis; enhancing traceability of design decisions as well as products; establishing simulated-use testing regimens; and altering advertising campaigns. Failure to incorporate any final guidance recommendations could be used against a manufacturer in product misuse liability suits, even those involving blatant consumer misuse and obvious risks or those that simply could not have been prevented by user-centered design.
While the guidance indicates it is not a rule and does not establish legally enforceable responsibilities, the tone of the draft guidance itself indicates that consumer misuse events will regularly be considered evidence of product defects. The reality is that companies regulated by the CPSC look at agency guidance as an obligation despite the disclaimers on enforceability. The draft guidance provides an excellent roadmap of human factors design considerations based on science from human system integration developed for NASA space flights, military systems, and industrial product design in addition to consumer products. But the draft guidance, untethered to specific products and applications, may present extraordinary costs and undue burdens given its applicability over such a wide range of consumer products. Congress required the CPSC to think critically about costs and benefits whether making rules (15 U.S.C. § 2058(c)) or deciding on whether a product presents an “unreasonable risk” by balancing the utility of product when the misused by consumers (15 U.S.C. § 2064; 16 C.F.R. §1115.6) for this very reason. Indeed, the draft guidance may go beyond the rulemaking authority of the CPSC because it does not tie its design recommendations to a specific product and the nature of the risk of injury associated with the product. As such, it might better be styled as a research project and investigation into the prevention of product –related injuries (15 U.S.C. §2052) than a guidance document.
Without following the enabling act’s requirements for cost benefit analysis, neither the CPSC nor the DOJ should use the guidance to justify enforcement actions or recall decisions. And yet the CPSC’s recent enforcement action against Britax, that alleges a design defect that manifests only with consumer misuse, evidences a zero tolerance policy for products that can be misused. The prosecution of the case will necessarily require CPSC to advance these human factors design principals that have never been subject to the rigors of the APA or the cost benefit analysis required by the Consumer Product Safety Act.
Not all consumer misuse can be designed away. Despite the best of intentions and the devotion of considerable resources, product designers cannot address the myriad ways we humans can make accidents happen. Some personal responsibility must still play a role in determining liability, whether those decisions are being made by regulators or in the courts.
Businesses should begin preparing to revisit internal regulatory reporting triggers – tuning them to take into account an aggressive consumer misuse perspective. To help direct and clarify the Commission’s position on human factors design elements and on consumer misuse, consumer product designers and manufacturers should consider options for commenting on the draft guidance both individually and as part of industry associations.
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