October 24, 2016

Frame Your Medical Device Defense Around ‘Locus of Control’

By Dr. Ken Broda-Bahm: 

Med Device

“Locus of Control” (Rotter, 1966) is a psychological concept referring to how an individual attributes responsibility over her or his own fate. There are important individual differences. Those with a high internal locus of control will attribute success or failure to one’s own skill and choices, while those with a high external locus of control will attribute it to luck or to circumstances. Of course, that is a pretty useful measure for jury selection, with defendants generally preferring the “individual responsibility” orientation of those who favor an internal locus of control, and plaintiffs generally seeking out the victim-focused orientation of those with a high external locus of control.

In medical device context, however, locus of control is more complicated, since there are at least three places that control could reside: with the patient, the doctor, or the device manufacturer. Adding in more levels (e.g., pharmaceutical companies, different members of the medical team, or different parts of the manufacturing company – sales, design, testing, etc.), that control can be further distributed. The correct answer, factually and legally, is often that all of these parties bear a measure of responsibility for what is within their own sphere of control. At the same time, in mock trials and post-verdict interviews with jurors, we often find that jurors will concentrate their greatest attention on one party’s control, seeing that party as having the greatest power and making the key choices. And it is generally not a good thing to be the party in that position, since jurors will scrutinize every one of your decisions and imaginatively construct scenarios of what you could have done differently. But neither is it a good thing to focus only on other parties and to keep one’s own responsibility to an absolute minimum, since that can look unrealistic or evasive. Instead, the goal is to realistically distribute: Take responsibility for what is within your sphere, but encourage jurors or other factfinders to rationally place other responsibility where it belongs.

To do that, it helps to know a jury’s likely baseline attitudes. In this brief article, I will share some new data bearing on Locus of Control in three areas of relevance to the medical device manufacturer. In the summer of 2016, Persuasion Strategies conducted a nationwide survey of 420 jury-eligible participants. I will highlight three implications from that survey data.

One, Look for Label Readers

We asked respondents whether they tend to read, skim, or ignore the label content when dealing with medicine or medical devices. Most claim to read the label word for word.

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Of course, we are measuring their reported behavior, not their actual behavior. But that possibly idealized version is what jurors will be applying to the parties they evaluate. Label readers tend to accept a personal locus of control for themselves and place that responsibility on others as well: not just a burden to read the label, but to assume the responsibility for the knowledge and the risks of using the medication or the product.

Two, Treat Your Warning as a Transfer of Responsibility

This is the basic way warnings should work: Once a user is warned, then responsibility transfers to that user who can make an individual choice of whether to assume the risk or not. What jurors hate is knowledge that the company has but doesn’t share. That is why “hidden danger” is such a common plaintiffs’ theme across products cases generally: Users cannot protect themselves against risks they do not know about.

In practice, this creates a low threshold for warnings, perhaps lower even than the science or the common sense would suggest. For example, when we asked survey respondents what that threshold should be for a medical device company, nearly two-thirds reported that “even a slight possibility of risk” justified a warning. Less than a third felt that there should be evidence of that risk.

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So while the public, jurors included, will complain about ubiquitous warnings for everything including hot coffee, when it comes to assessing control and responsibility in the deliberation room, jurors want that warning to be there and to be clear.

Three, Educate and Convince Regarding the Doctor’s Role

Medical device cases can sometimes carry the illusion of a direct transaction between a device company and a patient/end user, and plaintiffs’ attorneys do what they can to facilitate that illusion. It is often an easier assumption to make because jurors often do not understand the doctor’s role. They may see the device manufacturer’s size, resources, and name familiarity as automatic signs of greater control and power.

One situation where this gap in understanding can play a pivotal role in regards to off-label use. When we asked in our survey, a large majority (79 percent) either did not know whether off-label use is allowed or incorrectly believed that it is prohibited. And the less power they see in the doctor’s hands, the more power resides with the device maker.

In the context of an actual trial, of course, the actual jurors will be informed on the law. But interestingly, even after being informed, the idea of off-label use remains controversial.

In the survey, we asked a longer question:

“The government’s role regarding medical devices, through the FDA, is to restrict how a device company markets and labels its products, but not to restrict how doctors actually use the device with patients. When a doctor uses a product in what is called an “off-label” application, this is not prohibited by any regulation and is actually very common in American medicine. Do you think this situation is:”

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Experienced medical device litigators know that they will have to address this perception, both educating and convincing jurors that doctors not only do have that ability, but also should have that ability to exercise their own medical judgment on a case-by-case basis.

This is just a small sampling of the ways that locus of control can come into a case. In general, a good trial message is that, “We take responsibility for what is in our sphere…but several things are properly outside that sphere.”

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Other Posts on Medical Cases: 

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Rotter, J. B. (1966). “Generalized expectancies for internal versus external control of reinforcement”. Psychological Monographs: General & Applied. 80 (1): 1–28. doi:10.1037/h0092976.

Photo credit: 123rf.com, used under license. 

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