February 08, 2016 Articles

You're Only Human (Factored) as a Product Defender

By Jim O'Reilly

Human factors research has developed into a very intriguing intersection of culture, psychology, sociology, and other academic disciplines. At a recent national conference on pharmaceutical regulation, a major drug company official discussed with the audience how beneficial it has been for his research group to have six PhD-level scholars of human factors, overseeing the work of outside contractors who perform the field research on how their products are prescribed, consumed, and mixed with other drug and medical device products. His point is clear; marketers can understand the humans who take our products better when we assess their ways of consuming the products. How is the syringe filled by the nurse, how does he or she handle it, what are the points of exposure to needle sticks, etc.

So I came to the audience microphone and simply asked, are your lawyers aware that you are "self-destructing" the valuable defense that an unforeseeable misuse had occurred or a user error was the source of this injury? Oh, they have never asked, and we never assumed that they would need to know.

For the reader who regularly defends manufacturers, what are the names of the human factors research team at your client's company? Is it common for you to raise the defense of worker or user misuse, in motions rebutting causation claims? And if the misuse had been no surprise—because it had fit a scenario that your human factors specialists had tested among nurses or roofers or chemical processors, whomever your intended audience had been or will be—would the discovery of your human factors department's documents quickly scuttle your defenses?

To be clear, lawyers are humans, too; we master what we can about things with which we have aptitude or insight or both. Human factors experts study people and their predictable behaviors. Scholars are not necessarily gifted with wisdom about fatal errors that doctors may make. My transition from in-house attorney to academic did not grant me (or my students) deep insight into the future. The products I had defended were the result of huge amounts of consumer studies over many years. But these consumer products did not have the exciting interface that a new medical device would have, for example, to the disabled patient, and my client's brands were not a high-risk mixture of pharmaceutical A and ingredient B in dispenser C. This may be your product and your zone of risks.

Imagine the impact of human factors expertise on design of the medical product to make it safer. Assume that the company makes a conscious choice not to invest in the feature that would have prevented this plaintiff's harm. Is the insight about what could protect humans qualitatively different than data about the legal standard of "reasonably foreseeable misuse"? Surely the discovery request would draw objections on relevance. Psychologists, like all academics, tend to write in obscure jargon. A plaintiff looks for a smoking gun of the defendant's knowledge, but what if the human factors study is less clear than others might wish? How would the relevance of the human factors research be explained to the judge by the solo or smaller firm plaintiff's counsel, who did not have the staff of researchers with psychological measurement training that the corporation can routinely assemble? It is very interesting, but not necessarily admissible, to show the company performed a scenario study with multivariate analyses. But if the defense hinges upon the shockingly bad behavior of the injured person, yet the human factors department ran just that scenario in its planning, your client might as well settle as the jury and judge will find the harm quite literally foreseeable.

Our common goal is or should be to make our clients' products more useful, more safe, more affordable, and more valued. Lawyers who work with research-intensive product lines should hail the discoveries of the human factors team, deep in the client's research center, which discoveries move forward on each of those goals. I do not ever espouse "willful ignorance" of factual data about one's product. But the very careful decision to invest heavily into human factors research carries a future risk in the weeks after production of boxes or terabytes of data to the plaintiff's counsel. Is the user mistake a lone outlier on the graph? Was the ignition of the substrate a risk that the human factors team could foresee? Should attorneys try to vet the work of your human factors team? Again, we do not call for abandonment of useful formation of new knowledge about existing products. At the end of this reevaluation process, some policy change might happen. Or, then it might not: we're only human!

Keywords: litigation, products liability, human factors, consumer studies, defense, foreseeable misuse


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